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6 - 11 years
27 - 32 Lacs
Pune
Work from Office
About The Role : Job TitleQuality and Testing Engineer - AVP LocationPune, India Role Description Our Investments agile teams at Deutsche Bank - Private Bank (TDI) develop and maintain applications for securities business of Private Customers. Changes are generally announced on short notice due to regulatory requirements or time to market challenges. Quality and stability has priority together with time to market. By working in an Agile DevOps model, acting a pilot for Investments and actively improving the model, we achieve very high quality while continuously delivering value to our clients. Located in Germany and India, we work closely together using agile and virtual collaboration techniques and our teams diversity to reach our goals of continuous deployment, process improvement and internalizing engineering know how. As a Quality and Testing Engineer you will closely work together with business and operation units and bring functional testing, test management and test automation skills to enforce the development team within a Squad. You will extensively make use and apply test automation concepts and practices in the context of Deutsche Banks digitalization journey. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy, Best in class leave policy. Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your Key Roles & Responsibilities You are involved in the Software Development Lifecycle starting from analyzing requirements, maintaining test cases, developing test automation features and testing software - continuously improving these topics. Develop/ support test automation strategy for large complex projects in AGILE methodology. Develop / support non-functional testing automation strategy for large complex projects in AGILE methodology. Contribute to team agile planning activities and backlog prioritization and management. Collaborates with product line stakeholders to understand and develop strategies, frameworks relating to their emerging demands. Driving innovation/adoption of Industry practices through investigation/institutionalization of new tools/methods/standards. Ensures that testing activities are being conducted in accordance with the testing strategy and plan. Perform and achieve in sprint testing team and release goals. Create test documents likeTest Plan, Test Risk Assessments, and Test Results and make sure that they are reviewed and approved by appropriate stakeholders. Participate in estimation of User Stories in Story points. Create, Automate and Execute test cases to cover all user stories acceptance criteria and honor timely deliveries. Increase the test coverage and test speed by automating all possible test cases. Create and develop test automation frameworks. Integrate test automation framework into CI/CD pipeline. Ensure test flakiness is at a minimum. Participate and help in knowledge transfer sessions when necessary. Defects submission, monitoring, and retesting Keep demo sessions to prove acceptance criteria are met. Coordinate the preparation of test environments. Define and create all test data / test data generators needed for the tests. Maintain regression test pack. Align with dev team to understand the integration with different systems to execute System Integration Testing Provide regular status reporting to scrum team. Verify entry/exit criteria for all SIT, UAT phases. You actively participate and contribute into the sprint activities and ceremonies e.g. daily stand-up, Sprint planning, retrospectives, refinements etc. You collaborate with other team members to achieve the sprint objectives Your Skills and Experience Strong experience in requirements analysis for test case creation and test execution of user stories using tools like Quality Centre/ALM, Confluence , Jira ,SOAP UI, Filetransfer, SQL developer, Strong experience in development of Test Automation features using UFT (unified functional testing) and / or Selenium with Java Experience in API testing is a must. Experience in Postman is an additional benefit. Open for manual testing for at least a year in parallel to identifying automation candidates. Individual contributor with an attitude to learn and deliver. Pro-active team player with good communication skills as well as good English language skills. Experience with Agile/SCRUM environment including agile tooling and methodology together with Knowledge of investment business and its operations. How we'll support you Training and development to help you excel in your career. Coaching and support from experts in your team. A culture of continuous learning to aid progression. A range of flexible benefits that you can tailor to suit your needs.
Posted 1 month ago
- 1 years
5 - 9 Lacs
Jaipur
Work from Office
About The Role : Job TitleKYC Analyst, NCT LocationJaipur, India Role Description The Know Your Client (KYC) Analyst focuses on client onboarding (COB) and exceptions in line with regulatory standards and jurisdictions. The KYC Analyst provides regular communication to senior bank stakeholders on changes in KYC, Anti Money Laundering (AML) and Anti Financial Crime (AFC) areas and ensures any changes required are implemented with minimum disruptions. The KYC Analyst also assists the banks clients, managing all KYC and account opening requirements with appropriate governance and controls. They operate in an environment of strict adherence to Standard Operating procedures (SOPs) and Operation Level Agreements (OLAs) to achieve accurate and timely account opening to help execute trades What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy, Best in class leave policy. Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities The Know Your Client (KYC) Analyst focuses on client onboarding (COB) and exceptions in line with regulatory standards and jurisdictions. The KYC Analyst provides regular communication to senior bank stakeholders on changes in KYC, Anti Money Laundering (AML) and Anti Financial Crime (AFC) areas and ensures any changes required are implemented with minimum disruptions. The KYC Analyst also assists the banks clients, managing all KYC and account opening requirements with appropriate governance and controls. They operate in an environment of strict adherence to Standard Operating procedures (SOPs) and Operation Level Agreements (OLAs) to achieve accurate and timely account opening to help execute trades Your skills and experience Should have more than 6 months experience in Corporates and with good communication and system knowledge. How we'll support you Training and development to help you excel in your career. Coaching and support from experts in your team. A culture of continuous learning to aid progression. A range of flexible benefits that you can tailor to suit your needs. About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.
Posted 1 month ago
5 - 8 years
3 - 8 Lacs
Jaipur
Work from Office
About The Role : Job TitleRegulatory reporting team, Associate LocationJaipur, India Role Description The role is to perform a number of key functions that support and control the business in complying with a number regulatory requirements such as MiFID II, EMIR, CFTC and SFTR .This role forms part of a team in Bangalore that supports Regulatory reporting across all asset classesRates, Credit, Commodities, Equities, Loans and Foreign Exchange. Key responsibilities include day to day exception management MIS Compilation and User Acceptance Testing (UAT). This role will also indulge in supporting in-house tech requirements in terms of building out reports, macros etc. What we'll offer you Best in class leave policy Gender neutral parental leaves 100% reimbursement under child care assistance benefit (gender neutral) Flexible working arrangements Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Performing and/or managing various exception management functions across reporting for all asset classes, across multiple jurisdictions Ensure accurate, timely and completeness of reporting Working closely with our technology development teams to design system solutions, the aim to automate as much of the exceptions process as possible Liaising with internal and external teams to propose developments to the current architecture in order to ensure greater compliance with Regulatory requirements and drive improved STP processing of our reporting across all asset classes Perform root cause analysis or exceptions with investigation & appropriate escalation of any significant issues found through testing, rejection remediation or any other stream to senior management to ensure transparency exists in our controls Ability to build and maintain effective operational process and prioritise activities based on risk. Clear communication and escalation. Ability to recognize high risk situations and deal with them in a prompt manner. Documentation of BI deliverables. Support the design of data models, reports and visualizations to meet business needs Develop end-user reports and visualizations Your skills and experience 5-8years work experience within an Ops role within financial services. Graduate in Science/Technology/Engg./Mathematics. Regulatory experience (MIFIR, EMIR, Dodd Frank, Bank of England etc.) is preferred Preferable experience in Middle Office/Back Office, Reference Data and excellent in Trade Life Cycle (At least 2 asset Classes Equities, Credits, Rates, Foreign Exchange, Commodities) Ability to work independently, as well as in a team environment Clear and concise communication and escalation. Ability to recognise high risk situations and deal with them in a prompt manner. Ability to identify and prioritize multiple tasks that have potential operational risk and p/l impact in an often high-pressure environment Experience in data analysis with intermediate/advanced Microsoft Office Suite skills including VBA. Experience in building reports and BI analysis with tools such as SAP Business Objects, Tableau, QlikView etc. Advanced SQL Experience is preferred. How we'll support you Training and development to help you excel in your career Flexible working to assist you balance your personal priorities Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.
Posted 1 month ago
6 - 11 years
5 - 9 Lacs
Bengaluru
Work from Office
About The Role : Job Title - KYC Associate (#RYR2025) Location - Bangalore Role Description Operations provides support for all of Deutsche Banks businesses to enable them to deliver transactions and processes to clients. Our people work in established global financial centers such as London, New York, Frankfurt and Singapore, as well as specialist development and service centers in locations including Bucharest, Moscow, Pune, Dublin and Cary. We process payments in excess of a trillion euros across the banks platforms, support thousands of trading desks and enable millions of banking transactions, share trades and emails every day A dynamic and diverse division, our objective is to make sure that all our services are executed in a timely and professional manner, that risk is minimized and that the client experience is positive. We are proud of the professionalism of our people, and the work they do. In return, we offer excellent career development opportunities to foster skills and talent. In accordance with Anti-Money Laundering Requirements, Banks, such as Deutsche Bank AG ("DB"), are obliged to perform Know-your-client (KYC) reviews on all new clients they adopt. These checks and reviews are made in strict accordance with regulatory requirement and the banks internal policies. The project involves verification of the Client data, performing due diligence checks on the Clients, reviewing KYC documentation performing the risk assessment of the Client, liaising with the Business/Compliance, advising on KYC requirements and signing off on new client adoptions.The Reg & Tax analyst role is an operations function where you will be involved in reviewing various regulatory documents related to clients to ensure that all the regulatory requirements are met and the bank is in compliance. What we'll offer you Please be aware there are regional differences to DB benefits and you will need to check the correct package per advert. As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Responsible for verification of Client data Perform due diligence of new and existing clients covering a wide range of different client types including; Listed and Regulated, small/medium/ large private and public companies as well as more complex structures such as; SPVs, Co-operatives, Foundations and Funds, Governments, Joint Ventures, etc. Verifying KYC documentation of the Clients to be adopted/reviewed Perform the risk assessment of the Client to be adopted/reviewed Signing off on new client adoptions and periodic reviews Manage New Client Adoption or Periodic Review stream, to ensure that all requests are approved in accordance with regulatory requirements and the banks internal policies Manage exception ensuring that all SLAs defined with the Business on timeliness and quality are adhered Your skills and experience 6+ years of relevant work experience (AML/KYC/compliance related) within corporate financial services industry, Research/Analytics role in other Banks / KPOs etc Understanding of Control, Compliance, Investigation/chasing functions in banks Familiarity AML/KYC regulations and industry guidelines (FSA, JMLSG, 3rd EU Money Laundering Directive, MiFID) Ability to interpret regulatory guidelines and assessing risk scores and entity types Ability to interpreting alerts Ability to identifying trends and inconsistencies Understanding of end to end KYC process How we'll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm Our values define the working environment we strive to create diverse, supportive and welcoming of different views. We embrace a culture reflecting a variety of perspectives, insights and backgrounds to drive innovation. We build talented and diverse teams to drive business results and encourage our people to develop to their full potential. Talk to us about flexible work arrangements and other initiatives we offer. We promote good working relationships and encourage high standards of conduct and work performance. We welcome applications from talented people from all cultures, countries, races, genders, sexual orientations, disabilities, beliefs and generations and are committed to providing a working environment free from harassment, discrimination and retaliation. Visit Inside Deutsche Bankto discover more about the culture of Deutsche Bank including Diversity, Equity & Inclusion, Leadership, Learning, Future of Work and more besides.
Posted 1 month ago
2 - 6 years
7 - 12 Lacs
Bengaluru
Work from Office
About The Role : Job TitleRegulatory Control Analyst LocationBangalore, India Role Description The candidate for the AFC Centre of Excellence for KYC is supporting CB and IB KYC escalations to AFC, collaborating with the relevant Business stakeholders, Client Lifecycle Management and other AFC functions. Primary focus of the reviewer would be to ensure they review and approve the risk factor highlighted by CLM team as part of NCA/EDR/PRs Organization Deutsche Bank (DB) is committed to the highest standards of Anti-Money Laundering (AML), Sanctions & Embargoes, Anti-Bribery and Corruption (ABC) and Anti-Fraud & Investigations (AF&I) and wider Financial Crime (collectively referred to as Anti Financial Crime) prevention. The Management and all employees are required to adhere to these standards to prevent DB and our reputation from those who may intend to use our products and services for money laundering, bribery, corruption, fraud and/or Terrorist Financing (TF) purposes. AFC KYC COE Implement a dedicated Centre(s) of Excellence for the AFC element of the KYC file review, allowing customers to be reviewed once in review cycle. Below are some of the key principals . Achieve economies of scale through the creation of one functional team with sophisticated risk managers, under one global leader who is accountable for the AFC KYC file review and sign-off process.Ensure fulfilment of local regulations and regulatory expectations in an efficient, risk focused manner.Ensure sufficient resources to create and effectively maintain a follow the sun KYC file review aligned with ACO availability.Seek opportunities to geographically co-locate the CoE with respective 1LoD counterparties (i.e. align with the 1LoD Target Operating Model) to stimulate cooperation and strengthen the relationship What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Review and approve client escalations for Remediation, Regular Review, New Product Extensions and Event Driven Reviews within the agreedSLAs Ensure the generated client risk rating is in line withexpectations & procedures. Assess the risk factors identified through the due diligence provided by client lifecycle management (CLM) Apply subject matter expertise judgment as to relevance and/or materiality of Escalation triggers; i.e., can the overall assessment bedefended Engage with appropriate BLAFC specialist team where further escalation is required e.g., local BLAFC, AFBC, Sanctions, BIUetc. Liaise with CLM to obtain additional information or request ACO to conduct additional research whererequired Ensure outcome and rational is clearly documented within the KYC systems and / or escalated for furtherguidance Ensure that KYC reviews undertaken are in line with the KOPs guidelines andprocesses Contributing to the wider globalKYCCentre of Excellence programme, identifying best practices Deciding on new or existing clients that are escalated or deciding to escalate further to Governance Forums for review. Defining and implementing strategic TOM in-line with local/regional/global standards and change programmes. Your skills and experience Skills: Ability to identify and manage financial crime risks arising from regular reviews, event driven reviews, new client adoptions and new productextensions Strong communication, organizational, and interpersonal skills with the confidence to engage and advise professionally and persuasively with stakeholders. Proven analytical skills, problem solving ability, and a control mindset paired with meticulous attention to detail. Able to raise sensitive or potentially contentious issues in a constructive manner to reach appropriate solutions. Deadline driven with the ability to multi-task and work in a fast-paced environment. Ability to handle time-sensitive projects while focusing on the quality of work delivered. Self-motivated and proactive team player who takes ownership of assignments, thrives in a teamwork-oriented environment, and works well under pressure. Ability to work with various stakeholders across all 1LoD and 2Lod and manage expectations, without impacting the quality output. Experience Must be a graduate with any stream with at least 2-3 years experience in AFC or a related control related function within an international organization/bank in the Financial Services industry with extensive experience with the KYC process. People having a degree or diploma in AML/KYC will be preferred. A strong track record in risk and regulatory matters, ideally including: Good understanding of AFC risks and typologies in order to identify areas or instances of potential AFC risks and to address them appropriately. Experience of relevant regulations/laws and related circulars Financial Crime function expertise and should be considered a Subject Matter Expert (SME) in the Financial Crime area on relevant laws and regulations. Should be flexible with respect to work timings. Should be comfortable in working on MS Office tools using word and excel. How we'll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs
Posted 1 month ago
2 - 6 years
7 - 11 Lacs
Bengaluru
Work from Office
About The Role : In Scope of Position based Promotions (INTERNAL only) Job TitleAuditor, AS LocationBangalore, India Role Description As an Auditor in the Chief Operating Officer (COO) Operations audit team, based Bangalore, you will have a key role in the delivery of global audit coverage for the COO function. This varied role will play a key part in achieving sophisticated and insightful coverage of the high-risk operations landscape. This primarily includes auditing key Operations utilities and trade processing related aspects across multiple investment banking products and businesses. This may include (as examples) Derivative Operations, Loan Operations, Asset Services, Client on Boarding, Operational Tax Unit, Divisional Control & Regulatory Office (DCRO), and Payments. Whilst primarily operating as a team member, the candidate may on occasion be required to take a coordinating role. Further, the role plays an important part in contributing to risk and continuous audit assessment, as well as tracking and validation of risk remediation. The COO function is a Subject Matter Expert (SME) team within Group Audit. As such the role requires close liaison and co-ordination with senior managers and staff from other audit teams to facilitate effective coverage of key processing risks across the GA audit universe and to ensure the timely and high quality delivery of the audit plan. Finally, the individual will be expected to pro-actively propose and contribute to initiatives supporting the continuing development of the capability and effectiveness of the COO Operations audit team, as well as Group Audit overall. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under child care assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities We are seeking an individual with strong skills in the Operations arena, and a proven track record in audit or a related discipline. The individual will need to demonstrate that they are self-motivated and innovative, have strong communication skills, a delivery focus and be able to work effectively under pressure. The candidate must: Have investment banking experience with some knowledge of key banking products (e.g. Markets, Transaction Banking, Asset Management), Operations processes (e.g. client on-boarding, trade capture, reconciliations, settlements, payments, collateral management, corporate actions, regulatory reporting) and the controls within the various control functions. Be able to assist in planning, preparation, coordination and execution of audits. Track and validate risk remediation and closure of findings. Demonstrate competency to evaluate the adequacy and effectiveness of controls in the relevant operational and business areas in accordance with Group Audit methodology and the established risk assessment framework. Exhibit an understanding of risks relevant to the operations and wider bank environment, for example such as fraud scenarios. Good experience participating and supporting complex audits, and delivering to a high standard on time and on budget. Take responsibility for their own skill development, sharing expertise to help develop the capability of their colleagues, and contributing to the ongoing development of the global COO team and GA in general. The role will require occasional travel both regionally and globally The candidate will be required to complete all work assigned to them on a timely basis. This may also include ad hoc projects and special investigations. Your skills and experience A creative, tenacious and delivery oriented self-starter, the candidate will also need to demonstrate: Confidence, drive and enthusiasm. Excellent team working capabilities and an ability to build strong business and team relationships. A willingness to accept responsibility, a positive can do attitude and a delivery focus. Strong English communication skills, both oral and written. Fluency in other languages to a business standard is advantageous, but not mandatory. Notable (at least 3 years) experience in the disciplines outlined above is a pre-requisite. Relevant qualification preferred, such as Chartered Accountant, ACA, CPA or equivalent. . How we'll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs
Posted 1 month ago
1 - 4 years
4 - 8 Lacs
Bengaluru
Work from Office
About The Role : Job TitleTransaction Surveillance, NCT Location:Bangalore, India Role Description The Payments Processing Operator is responsible for the accurate and timely processing of all types of payments including processing of physical cash/valuables, as well as the handling of cash related investigations. This includes the processing of time-critical, complex transactions on behalf of the Banks internal and external clients, cash-related investigations involving enquiries from clients and internal stakeholders on cash payments before and after execution. It often involves time critical, potentially complex or in some cases regulated tasks including interaction with internal and external stakeholders. The Payments Processing Operator undertakes the complete and accurate capturing of payment transactions including physical cash/valuables transactions, ensuring that all payment-related information and relevant parties are processed according to established Service Level Agreement (SLAs) and industry guidelines. In addition, the Operator should ensure that procedures are properly executed to reduce processing risk and identify potential areas for process improvement whether internally within the Bank or for our clients. The Payments Processing Operator may also be in direct contact with clients in relation to payment processing offered by the Bank if this is agreed with respective front office functions. They may need to deal with the escalation and remediation of client complaints as well as managing relationships with the front office and other internal and external parties at an appropriate level. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under child care assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Processing Standards Process items adhering to procedures and cut-off times. Assist the team in the day to day operations. Liaise with the sending location in case of any clarification. Communicate to the team all process related clarifications received from the sending location. Collate data regarding process issues and communicate the same to the Manager. Carry out all the EOD functions as per checklists and maintain the relevant records. Ensure that all self-assessment reports and backup papers are signed by the responsible person after checking and the report is countersigned by the Team Manager. Maintain a record of all the relevant changes in procedural aspects Collate data regarding changes to the KOP and communicate the same to the Manager. Ensure training of new recruits as per the Training Module. To ensure proper backups are created within the department Escalation Escalate issues to supervisors and managers as per the escalation procedure. Keep Team Manager advised of the exceptional occurrences, to enable appropriate action.. Ensure that all procedures laid down for process are adequately followed. Ensure compliance of internal regulations To escalate any process related ambiguities to their respective supervisors or manager for clarification Compliance To communicate all potential business opportunities which have been identified in the course of regular transaction and to assist the management in the efforts for business development Business Opportunities To achieve the Job objectives set within the timelines agreed. Contribution to innovation. Contribute ideas with the objective of achieving excellence in service quality. Carry out the monthly departmental self-assessments, based on the checklists. Ensure that the checking is done in true spirit and evidences all control lapses with suggested actions. Additional Responsibilities Ensure all amendments and or updates to the KOP are made on the defined timelines. Ensure training of new recruits as per the Training Module. Carry out tests or quizzes to assess the trainees Maintain all relevant training records. Assist the manager in preparation of various team related MIS Your skills and experience Clear understanding of Payments flow Well versed with SWIFT Risk and Regulatory Payments, SWIFT Back office operation, Operation Risk Minimum Graduation in any stream. How we'll support you Training and development to help you excel in your career Flexible working to assist you balance your personal priorities Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.
Posted 1 month ago
- 1 years
5 - 9 Lacs
Mumbai
Work from Office
About The Role : Job TitleKYC, NCT LocationMumbai, India Role Description The Know Your Client (KYC) Analyst focuses on client onboarding (COB) and exceptions in line with regulatory standards and jurisdictions. The KYC Analyst provides regular communication to senior bank stakeholders on changes in KYC, Anti Money Laundering (AML) and Anti Financial Crime (AFC) areas and ensures any changes required are implemented with minimum disruptions. The KYC Analyst also assists the banks clients, managing all KYC and account opening requirements with appropriate governance and controls. They operate in an environment of strict adherence to Standard Operating procedures (SOPs) and Operation Level Agreements (OLAs) to achieve accurate and timely account opening to help execute trades. The Know Your Client (KYC) Analyst focuses on client onboarding (COB) and exceptions in line with regulatory standards and jurisdictions. The KYC Analyst provides regular communication to senior bank stakeholders on changes in KYC, Anti Money Laundering (AML) and Anti Financial Crime (AFC) areas and ensures any changes required are implemented with minimum disruptions. The KYC Analyst also assists the banks clients, managing all KYC and account opening requirements with appropriate governance and controls. They operate in an environment of strict adherence to Standard Operating procedures (SOPs) and Operation Level Agreements (OLAs) to achieve accurate and timely account opening to help execute trades. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities The Know Your Client (KYC) Analyst focuses on client onboarding (COB) and exceptions in line with regulatory standards and jurisdictions. The KYC Analyst provides regular communication to senior bank stakeholders on changes in KYC, Anti Money Laundering (AML) and Anti Financial Crime (AFC) areas and ensures any changes required are implemented with minimum disruptions. The KYC Analyst also assists the banks clients, managing all KYC and account opening requirements with appropriate governance and controls. They operate in an environment of strict adherence to Standard Operating procedures (SOPs) and Operation Level Agreements (OLAs) to achieve accurate and timely account opening to help execute trades Your skills and experience Should have more than 6 months experience in Corporates and with good communication and system knowledge. How we'll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs
Posted 1 month ago
2 - 6 years
8 - 12 Lacs
Bengaluru
Work from Office
About The Role : Job TitlePayments Processing Analyst, NCT LocationBangalore, India Role Description The Payments Processing Operator is responsible for the accurate and timely processing of all types of payments including processing of physical cash/valuables, as well as the handling of cash related investigations. This includes the processing of time-critical, complex transactions on behalf of the Banks internal and external clients, cash-related investigations involving enquiries from clients and internal stakeholders on cash payments before and after execution. It often involves time critical, potentially complex or in some cases regulated tasks including interaction with internal and external stakeholders. The Payments Processing Operator undertakes the complete and accurate capturing of payment transactions including physical cash/valuables transactions, ensuring that all payment-related information and relevant parties are processed according to established Service Level Agreement (SLAs) and industry guidelines. In addition, the Operator should ensure that procedures are properly executed to reduce processing risk and identify potential areas for process improvement whether internally within the Bank or for our clients. The Payments Processing Operator may also be in direct contact with clients in relation to payment processing offered by the Bank if this is agreed with respective front office functions. They may need to deal with the escalation and remediation of client complaints as well as managing relationships with the front office and other internal and external parties at an appropriate level. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Processing Standards Process items adhering to procedures and cut-off times. Assist the team in the day to day operations. Liaise with the sending location in case of any clarification. Communicate to the team all process related clarifications received from the sending location. Collate data regarding process issues and communicate the same to the Manager. Carry out all the EOD functions as per checklists and maintain the relevant records. Ensure that all self-assessment reports and backup papers are signed by the responsible person after checking and the report is countersigned by the Team Manager. Maintain a record of all the relevant changes in procedural aspects Collate data regarding changes to the KOP and communicate the same to the Manager. Ensure training of new recruits as per the Training Module. To ensure proper backups are created within the department Escalation Escalate issues to supervisors and managers as per the escalation procedure. Keep Team Manager advised of the exceptional occurrences, to enable appropriate action.. Ensure that all procedures laid down for process are adequately followed. Ensure compliance of internal regulations To escalate any process related ambiguities to their respective supervisors or manager for clarification Compliance To communicate all potential business opportunities which have been identified in the course of regular transaction and to assist the management in the efforts for business development Business Opportunities To achieve the Job objectives set within the timelines agreed. Contribution to innovation. Contribute ideas with the objective of achieving excellence in service quality. Carry out the monthly departmental self-assessments, based on the checklists. Ensure that the checking is done in true spirit and evidences all control lapses with suggested actions. Additional Responsibilities Ensure all amendments and or updates to the KOP are made on the defined timelines. Ensure training of new recruits as per the Training Module. Carry out tests or quizzes to assess the trainees Maintain all relevant training records. Assist the manager in preparation of various team related MIS Your skills and experience Clear understanding of Payments flow Well versed with SWIFT Risk and Regulatory Payments, SWIFT Back office operation, Operation Risk Minimum Graduation in any stream. How we'll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs
Posted 1 month ago
- 1 years
4 - 8 Lacs
Bengaluru
Work from Office
About The Role : Job TitleKYC Associate LocationBangalore, India Role Description The Know Your Client (KYC) Analyst focuses on client onboarding (COB) and exceptions in line with regulatory standards and jurisdictions. The KYC Analyst provides regular communication to senior bank stakeholders on changes in KYC, Anti Money Laundering (AML) and Anti Financial Crime (AFC) areas and ensures any changes required are implemented with minimum disruptions. The KYC Analyst also assists the banks clients, managing all KYC and account opening requirements with appropriate governance and controls. They operate in an environment of strict adherence to Standard Operating procedures (SOPs) and Operation Level Agreements (OLAs) to achieve accurate and timely account opening to help execute trades What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities The Know Your Client (KYC) Analyst focuses on client onboarding (COB) and exceptions in line with regulatory standards and jurisdictions. The KYC Analyst provides regular communication to senior bank stakeholders on changes in KYC, Anti Money Laundering (AML) and Anti Financial Crime (AFC) areas and ensures any changes required are implemented with minimum disruptions. The KYC Analyst also assists the banks clients, managing all KYC and account opening requirements with appropriate governance and controls. They operate in an environment of strict adherence to Standard Operating procedures (SOPs) and Operation Level Agreements (OLAs) to achieve accurate and timely account opening to help execute trades Your skills and experience Should have more than 6 months experience in Corporates and with good communication and system knowledge. How we'll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.
Posted 1 month ago
10 - 16 years
10 - 15 Lacs
Vadodara
Work from Office
Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Assistant Manager/ Deputy Manager based at our Corporate Office - Vadodara, Gujarat. Job Criteria: B.Pharm or M.Pharm qualification having experience between 10 - 15 yrs. with dossier filling experience in MEXICO Countries. Knowledge for review of quality documents like executed batch documents, method validation, change Good communication skill Job Responsibility: Should have through knowledge of Mexico submission. Should have understanding for requirements of Mexico. Should have understanding for review of regulatory documents like batch record, specifications, COAs, stability data, change control, process validation report etc. Should have knowledge of review of method validations, chromatograms, dissolution profile, raw data etc. Interested candidate can share cv on creyesha.macwan@alembic.co.in
Posted 1 month ago
10 - 17 years
20 - 30 Lacs
Bengaluru
Work from Office
Job Title: Informatics Qualification Postgraduate in Science/MCA with a minimum of 10- 18 years of IT experience in the Pharmaceutical / Life science domain Technical Skills Experience in demonstrating a track record of delivering scientific solutions in the pharmaceutical and CRO industry. Experience in the implementation of Informatic applications like (Electronic Laboratory Notebooks(elNB), Laboratory Information Management System, Chromatography Data system (CDS) and other scientific applications. Experience with Software development life cycle (SDLC) and Computer System Validation (CSV). Should have experience in running projects with CSV life cycle. Candidate should have knowledge of current regulatory & Guidelines (GAMP5) for CSV, i.e. 21 CFR Part 11 ERES, Part 820, Part 210 & 211, EU Annex 11, ICHQ9 and SOP requirements of computerized systems w.r.t. data security, traceability and integrity. Candidate should be familiar with GCP, GLP and GMP guidelines/SOPs. The candidate should have skills in managing Regulatory & Client Audits (experience in supporting internal and external audits). Other Skills: Strong leadership, communication, consulting and influencing skills. Must have experience in resource management - channelizing resources to track current and future program resource assignments. Must have excellent team collaboration skills and the ability to lead and motivate cross-functional teams. Strong analytical and communication skills are required. Roles and Responsibilities: Responsible for supporting informatics applications of the assigned departments. In collaboration with the scientific community identify, evaluate and implement software applications meeting business requirements. Implement new projects/solutions as per business needs. Coordinates between scientists and vendors for any solution development/implementation Ensure effective utilization of scientific systems and applications Coordinate with Syngene clients and/or vendors to roll out scientific applications extended to Syngene Facilitate computer system validation and ensures that scientific applications are GxP compliant as per the operating unit requirements Responsible for ensuring 21 CFR Part 11 compliance for enterprise & standalone applications Focus on near-zero downtime for enterprise applications Technical support and administration of scientific and associated applications. Challenges / error handling, escalation and troubleshooting of scientific and associated applications. Responsible for effective coordination among clients, operating unit and internal IT team for the application / infrastructure challenges faced by the operating unit to minimize or eradicate the downtime Responsible to provide the right solution for the challenges faced by the operating units Responsible for implementation / suggestion of any IT related process improvements for the operating units Location: Bangalore
Posted 1 month ago
3 - 4 years
4 - 6 Lacs
Ahmedabad
Work from Office
Handle financial reporting, tax filings, audits, and compliance for US-based accounts. Analyze financial statements, provide insights, and ensure regulatory adherence.
Posted 1 month ago
10 - 15 years
45 - 60 Lacs
Bengaluru
Work from Office
Job Title: Product, Packaging and Process Commercialization Lead (Beverages Business) Job Summary : The Incumbent is responsible for leading the development / reapplication, commercialization and optimization of packaging and product solutions pan India. This role involves managing packaging projects, reapplication of packaging projects across bottling plants, drive packaging supplier quality and material quality and driving innovative packaging solutions that meet market demands and sustainability goals. The manager primarily oversee the commercialization process, ensuring seamless transition from product & package adaptation (after development by R&D) to market launch. Key Responsibilities: Packaging Commercialization: Lead the reapplication and commercialization of packaging solutions for new and existing products / package. Collaborate with cross-functional teams including marketing, product & package development (R&D), Finance, Procurement, Quality and manufacturing to ensure product / packaging meets all requirements. Collaborate with R&D, Design, and Manufacturing teams to ensure packaging design feasibility. Oversee the creation of packaging prototypes and conduct trials to validate performance and durability along with R&D. Source and qualify packaging suppliers and drive packaging supplier quality and material quality Trouble Shooting of Packaging material and product process for efficiency and productivity in manufacturing lines (there by improvement in yield and reduction in wastages). Ensure packaging designs are cost-effective, sustainable, and align with brand standards. Manage packaging testing, validation, and consult for regulatory compliance. Product Commercialization: Develop and implement commercialization strategies to successfully launch new products innovations. Collaborate with Cross-Functional Teams (CFTs) to ensure product readiness including label, RMPM etc readiness for launch of product across plants. Coordinate with marketing, sales, and distribution teams to ensure timely and effective product launches. Work for improvement of process of manufacturing (syrup / MMI / technology) to ensure right consumer experience and best efficiencies. Monitor market trends and consumer preferences to inform commercialization plans. Develop and execute product scale-up and manufacturing plans. Ensure regulatory compliance and quality standards as stated by R&D and Quality. Manage project timelines, budgets, and resources to meet commercialization goals. Process Commercialization: Develop and implement efficient manufacturing processes and modify as per the product / packaging launches needs. Collaborate with Engineering and Operations teams to design and install equipment. Optimize production workflows and reduce costs. Ensure process validation and regulatory compliance. Vendor and Supplier Management: Establish and maintain relationships with packaging suppliers and vendors. Manage supplier performance to ensure quality and cost-efficiency including packaging supplier audit & system enhancement. Source new materials and technologies to enhance packaging solutions in collaboration with Procurement. Quality Control and Improvement: Implement quality control processes to ensure packaging integrity and product protection. Analyse packaging performance data and drive continuous improvement initiatives. Resolve packaging issues and implement corrective actions as needed. Team Leadership and Development: Lead and mentor a team of packaging engineers and specialists. Foster a collaborative and innovative team environment. Provide training and development opportunities for team members.
Posted 1 month ago
2 - 3 years
7 - 12 Lacs
Kolkata, Mumbai, New Delhi
Work from Office
The Compliance and Governance Associate will support the team by managing administrative and operational tasks to ensure the effective implementation of policies and procedures. Key Responsibilities Collect, review, and maintain records as required under Compliance and Governance and related ESG policies, including: Counterparty Screening processes Whistleblower and corporate feedback channel reporting Corporate Social Responsibility activities Donation requests Business Courtesy reporting and records Conflicts of Interest disclosures Sanctions and E&S Red Flag Risk Screenings Maintain and update Compliance and Governance program documentation on SharePoint, including: Incorporating regulatory changes or internal policy updates and version control Configuring and organizing SharePoint libraries for optimal accessibility and security Manage and support Compliance and Governance training programs, and ad hoc ESG-related training, including: Develop the annual training schedule and coordinate with other departments (HSSE, IT, ESG) on the overall training schedule for employees Track training and attestation completion and maintenance of metrics Provide user management support for training platforms Prepare ad hoc, daily, weekly, monthly and/or quarterly Compliance and Governance metrics reports for management and board reporting Collaborate with IT to design, develop and maintain a Compliance and Governance dashboard for real-time metrics Support the implementation and oversight of the enterprise risk management system, including maintaining governing policies, an internal risk register, and applicable controls Support Compliance testing and internal audits, including tracking results and remediation requirements Provide administration support for the team, including: Maintain a centralized calendar for Compliance and Governance activities Schedule calls and meetings, manage travel arrangements, and process invoice payment Any other compliance initiatives and third-party engagement processes as business need Education Bachelors degree Experience 2-3 years of relevant experience in compliance or governance Prior experience within the energy or infrastructure sector preferred Skills Proficient in Microsoft Office and Power BI Familiarity with compliance management tools (e.g., Navex) Basic understanding of compliance principles, including anti-bribery, anti-corruption, and ESG concepts, is a plus Strong oral and written communication skills in English, including the ability to create clear and concise documentation and reports Excellent interpersonal skills, with the ability to collaborate with diverse teams and handle sensitive information with discretion Analytical ability with strong attention to detail Proactive, goal-oriented approach with consistent follow-through on tasks and projects A curious and creative mindset, eager to learn and contribute to cross-functional teams
Posted 1 month ago
7 - 12 years
3 - 7 Lacs
Mumbai
Work from Office
Role: Closed file review & audit 1-Handling closed / open file review for third party administrator & inhouse claims 2-Recoveries from third party administrator for claims processed with errors 3-Highlight areas of improvement 4-Monthly reports to be published Candidate must have: 1-In-depth knowledge of medical cases with exposure to ailment treatments, policy coverages for OPD/hospitalization/personal accident/ travel claims 2-Good interpersonal skills 3-Must be proactive & effective learner 4- Must have previous experience of Audit 5- Good Analytical, Communication and Negotiation skills 6- Familiar with Basic Microsoft Excel and regulatory changes 7- Minimum 7 years of experience in general insurance Accident & Health claims Qualifications Degree in medicine (BHMS/BAMS/MBBS) At Liberty General Insurance , we create an inspired, collaborative environment, where people can take ownership of their work; push breakthrough ideas; and feel confident that their contributions will be valued, and their growth championed. We have an employee strength of 1200+ spread over a network of 116+ offices in 95+ cities, across 29 states. Our partner network consists of about 5000+ hospitals and more than 4000+ auto service centers. We believe and live by our values every day - Act Responsibly, Be Open, Keep it Simple, Make things better and Put People First. For learning about our key USPs, you can go visit our website. Working with Liberty also provides you an opportunity to experience One Liberty Experience . We create the One Liberty experience through Providing Global exposure to employees by including them in cross country projects that gives them opportunities to work with diverse teams within & outside India. Fosters Diversity, Equity & Inclusion (DEI) to create equitable career opportunities Flexi Working arrangements. If you aspire to grow & build your capabilities to work in a global environment, Liberty is the place for you!
Posted 1 month ago
6 - 8 years
14 - 17 Lacs
Hyderabad
Work from Office
The Senior Associate, Global Submission Management – Americas, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the North American context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions. Roles & Responsibilities: Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans. Participation in information system and software update projects as well as ongoing system validations Serve as point of contact between Amgen’s functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM. Independently remain current on guidance (internal/external) and translate requirements into operational activities. Represent departmental expertise on regulatory projects and regional/global workstreams. Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective Contribute to the development of the strategy for communicating with global health authorities Initiate, lead and manage process development and improvement Participation in information system and software update projects as well as ongoing system validations Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Advanced knowledge of Veeva Vault RIM and the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Advanced knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Advanced knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred) Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM, Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Basic Education and Experience: Master’s degree and 3-4 years of directly related experience OR Bachelor’s degree and 4-6 years of directly related experience OR Associate’s degree and 6-8 years of directly related experience OR High school diploma / GED and 8+ years of directly related experience Preferred Education and Experience: Practical experience with submission requirements for US, Canada and South America
Posted 1 month ago
2 - 7 years
13 - 17 Lacs
Hyderabad
Work from Office
Manager - International Regulatory Lead Role Name Manager – International Regulatory Lead (IRL) Department Name International Regulatory Team, Global Regulatory Affairs Role GCF 5A ABOUT THE ROLE Role Description: The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans). Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio. Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate. Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing. Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes. Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management. Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams. Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations. Partners with peers to agree on product strategy including projected submission and approval time. Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status. Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function. Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products. Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. Basic Qualifications and Experience: Doctorate degree OR Master's degree and 10+ years of relevant regional regulatory experience OR Bachelor's degree and 12+ years of relevant regional regulatory experience Functional Skills: Must-Have Skills: Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and products Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities. Good-to-Have Skills: Ability to resolve conflicts and develop a course of action leading to a beneficial outcome Cultural awareness and sensitivity to achieve results across country, regional and international borders. Soft Skills: Strong communication skills, both oral and written Ability to understand and communicate scientific/clinical information Ability to work effectively with global, local and virtual teams High degree of initiative and self-motivation Planning and organizing abilities Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Good negotiation and influencing skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Posted 1 month ago
2 - 5 years
1 - 4 Lacs
Hyderabad
Work from Office
Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Collaborate with team members to resolve problems and escalate issues Record and maintain written redaction strategy for the study and product Manage timelines and coordinate work across team Required Skills: Experience understanding and interpreting data/information and its practical application Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through Ability to follow controlled processes Excellent spoken and written English Project management skills, including ability to prioritize work in order to meet required deadlines Problem solving ability Basic Qualifications: Degree with 2-5 years of experience working with regulatory documents in a biotech/ pharmaceutical environment Familiarity with clinical research and clinical regulatory documents Knowledge of clinical trial disclosure regulations, guidelines, and best practices ? EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Posted 1 month ago
5 - 9 years
12 - 16 Lacs
Hyderabad
Work from Office
HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission - to serve patients - drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. Regulatory Affairs Manager – Devices What you will do Let’s do this. Let’s change the world. In this vital role you will support development and execution of regulatory strategies and filings for new and existing drug delivery devices and combination products, establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. Responsibilities: Support the development, communication, implementation, and maintenance of JAPAC regulatory strategic plans Lead and/or support JAPAC health agency engagements Lead and/or support JAPAC filing activities and associated health agency inquiries Support device design controls activities and documentation reviews Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions in the JAPAC region Perform change control regulatory assessments as it relates to JAPAC Develop and support implementation and maintenance of internal regulatory processes Perform device determination decisions for regulated items to be developed and/or used in JAPAC region Support supplier engagement teams and due diligence activities in the JAPAC region Review regulatory sections in development, quality, and supply agreements that impacts JAPAC region Support regulatory compliance initiatives in the JAPAC region What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree; or Master’s degree and 2 years of pharma/biotech and/or medical device regulatory affairs experience; or Bachelor’s degree and 4 years of pharma/biotech and/or medical device regulatory affairs experience Preferred Qualifications: Master’s degree in regulatory affairs, engineering, or life sciences 6 or more years of experience in medical device regulatory affairs Experience in design controls, manufacturing, process development, quality assurance, quality control, or analytical development Experience in drug delivery device or diagnostics device regulatory submission process Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms
Posted 1 month ago
4 - 9 years
9 - 13 Lacs
Hyderabad
Work from Office
Manager - International Regulatory Lead Role NameManager – International Regulatory Lead (IRL) Department NameInternational Regulatory Team, Global Regulatory Affairs Role GCF5A ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description: The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to - optimize product development and regulatory approvals in International countries - develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans). Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio. Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate. Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing. Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes. Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management. Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams. Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations. Partners with peers to agree on product strategy including projected submission and approval time. Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status. Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function. Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products. Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. Basic Qualifications and Experience: Doctorate degree OR Master's degree and 3 years of relevant regional regulatory experience OR Bachelor's degree and 5 years of relevant regional regulatory experience OR Associate degree and 10 years of relevant regional regulatory experience OR High school diploma/GED and 12 years of relevant regional regulatory experience. Functional Skills: Must-Have Skills: Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities. Good-to-Have Skills: Ability to resolve conflicts and develop a course of action leading to a beneficial outcome Cultural awareness and sensitivity to achieve results across country, regional and international borders. Soft Skills: Strong communication skills, both oral and written Ability to understand and communicate scientific/clinical information Ability to work effectively with global, local and virtual teams High degree of initiative and self-motivation Planning and organizing abilities Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Good negotiation and influencing skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Posted 1 month ago
7 - 11 years
8 - 13 Lacs
Hyderabad
Work from Office
The RA CMC Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. The RA CMC Senior Manager may have staff oversite. Key Activities Contributes to product teams and acts as Global RA-CMC lead or supervisor for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team man a gement. May m anage and develop junior staff. Key Responsibilities Include: Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products at varying stages of development, Works with external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally Identifies regulatory risks across products within the defined scope, communicates these risks, and ensures aligned plans for mitigation Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments Develop response strategy and respond to health authority questions Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans Liaise with local regulatory teams to align on filing strategy Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system Follow established department regulatory processes to ensure cross-product alignment May manage staff Knowledge and Skills Regulatory CMC- specific regulatory knowledge & experience Staff management and development Education & Experience (Basic) Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and10 years of directly related experience OR High school diploma / GED and12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience
Posted 1 month ago
1 - 3 years
3 - 6 Lacs
Hyderabad
Work from Office
Roles and Responsibilities Performs document-level QC (including abbreviations, references to sources, data in text versus data in tables, figures, or graphs, etc.) to ensure submission readiness quality Ensures the consistency and accuracy of layouts, fonts, margins, styles, and spacing, logical content organization, and proper use of headings, tables, images, and footnotes applying Amgen submission readiness formatting guidelines to create professional documents Coordinates document collection with cross-functional team members and ensures publishing readiness of the documents Participates in collaborative team activities for noncomplex documents, including support to collect input from authors/reviewers Participates in the cross-functional document review process Participates in project management activities, i.e., timeline tracking and scheduling meetings with team members Learns and uses organizationally required authoring tools and technology platforms Attends cross-functional meetings with writers and departments, as appropriate, to share and gather information relevant for successful completion of assigned documents Documents in scope include, but are not limited toClinical Study Reports, Observational Research Study Reports, Plain Language Summaries, Investigator’s Brochures, local Risk Management Plans, noncomplex Original Protocols/ Protocol Amendments, Plain Language Protocol Summaries, and Informed Consent Forms Understands and complies with SOPs, templates, best practices, policies, Regulatory Writing Style Guides Compiles and maintains product-specific reference libraries across therapeutic areas Basic Qualifications Graduated with a Bachelor’s degree in science from an accredited college or university Preferred Qualifications 1-2 years of experience formatting, performing QC reviews, and managing the coordination of regulatory/clinical documents at a pharma/biotech or similar organization Some scientific or medical knowledge Some exposure to basic statistical and medical communication principles Strong oral and written communication skills Able to collaborate with others and build solid and positive relationships with cross-functional team members Able to work independently and problem solve Attention to detail and accuracy Organizational skills in time and project management, including ability to manage multiple projects simultaneously Strong knowledge of document management systems and typical office applications (eg, Microsoft Office, SharePoint)
Posted 1 month ago
3 - 6 years
5 - 8 Lacs
Hyderabad
Work from Office
PRODUCT QUALITY SPECIALIST What you will do Let’s do this. Let’s change the world. In this vital role you will provide technical expertise and product leadership to the Product Quality (PQ) organization. As a product support staff in Quality, the Product Quality Specialist has responsibility for working with Product Quality Leaders (PQL), International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other groups on projects including support of product specifications, in-process controls, periodic and annual product review, and complaint resolutions. Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we’re employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients. This role will support one or more late-stage and/or commercial biologics or synthetics products. The individual will provide project support to the relevant Product Quality Team (PQT) to implement and manage strategy for Quality to meet the Product Quality goals. The individual will be directly responsible for Product Quality related tasks including authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (document management system, complaint resolution system, data systems), and product data management, including stability, comparability assessments, periodic and annual product reviews (APR). In addition, the candidate will be expected to play a role in supporting Product Quality initiatives intended to ensure the overall product health. Support PQ work for late-stage and/or commercial biologic or synthetic programs, including actions required for the PQT, APR, specifications, comparability, stability programs, and PQ owned regulatory filing sections and responses to questions (RTQ) Support science and risk-based evaluation of complex process and product quality data such as in-process, release and stability data, complaints, method performance etc. What we expect of you Basic Qualifications and Experience: Doctorate degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 2 years of Quality, Operations, Scientific, or Manufacturing experience, or Master’s degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 6 years of Quality, Operations, Scientific, or Manufacturing experience, or Bachelor’s degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 8 years of Quality, Operations, Scientific, or Manufacturing experience or Preferred Qualifications: Must-Have Skills: Demonstrate proficiency in oral and written communication of complex information to Product Quality team members and peers Demonstrate proficiency in knowledge of cGMP and international regulatory expectations Strong scientific data management and organization skills with attention to detail Ability to deliver high quality results and adhere to project timelines using computer-based GMP Quality systems Ability to build and maintain multi-functional relationships and strong partnerships through written and verbal communication skills Good-to-Have Skills: Experience working virtually on a multi-functional team in a matrix environment across multiple time zones Expertise in computer applications such as Veeva, Spotfire, SHINY Expertise in MS Office (Word, Excel, PowerPoint, MS Teams) Soft Skills: Analytical and problem-solving skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Posted 1 month ago
5 - 8 years
7 - 10 Lacs
Hyderabad
Work from Office
About The Role : Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC and/or Device submission execution for Amgen products across phases of development, modality, and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing and/or over seeing preparation of submission content plans for CMC submissions including, CMC IND/CTAs and amendments, Investigational Device Exemption (IDE)/Performance Study Application (PSA)/ Clinical Investigation Application (CIA), new marketing applications, facility registration and renewals, post-market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC and/or Device submissions and related communications in the document management system Initiate and maintain CMC product and/or Device timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Doctorate degree OR Master’s degree and 5 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 7 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience managing or hovering staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Experience in IVD, Device or Combination Product regulatory submission process Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms
Posted 1 month ago
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The regulatory job market in India is experiencing growth as companies across various industries are focusing more on compliance and risk management. Regulatory professionals play a crucial role in ensuring that organizations adhere to laws and regulations set by the government, industry bodies, and other regulatory authorities.
The average salary range for regulatory professionals in India varies based on experience and expertise. Entry-level positions typically start around INR 4-6 lakhs per annum, while experienced professionals can earn upwards of INR 15-20 lakhs per annum.
In the regulatory field, career progression often follows a trajectory from Regulatory Analyst to Regulatory Specialist, and then to Regulatory Manager or Director. Professionals can further specialize in areas such as Compliance, Risk Management, or Quality Assurance.
As you prepare for regulatory job opportunities in India, remember to showcase your knowledge, skills, and experience effectively during interviews. Stay updated with the latest regulatory trends and developments to stand out in the competitive job market. Best of luck in your job search!
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