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5.0 - 9.0 years
0 Lacs
haryana
On-site
The primary responsibility of this role is to manage Regulatory Affairs in compliance with relevant regulations and guidelines for the organization. As a Regulatory Affairs Manager at DDReg, you will be involved in reviewing clinical, biopharmaceutical, non-clinical, and labelling documentation. Your duties will include preparing and reviewing non-CMC sections, Variations, site transfers, and conducting post-approval gap analysis. Additionally, you will support the regulatory function through document management, electronic submission compilation, and other group management activities as needed. Collaboration with various departments such as Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, and Research and Development will be necessary to ensure regulatory compliance and operational excellence. Your responsibilities will involve providing high-quality reviews of CTD sections for regulatory filings to various regulatory authorities such as EMA, UK MHRA, National Agencies of EU Member states, Canada, Australia, and other markets globally. You will actively contribute to developing and implementing regulatory strategies, processes, and timelines for global approval. Conducting Gap Analysis of Non-CMC sections, authoring and compiling CTDs sections, preparing labelling documentation, managing labelling changes, and ensuring compliance with regulatory guidelines will be key aspects of your role. Furthermore, you will be required to demonstrate expertise in regulatory matters, collaborate with internal and external stakeholders, and provide technical consultation and advice on strategy and industry best practices. To excel in this role, you should possess a Bachelor's or Master's degree in Pharma and have at least 5+ years of relevant experience in the pharmaceutical/CRO industry. Strong project management skills, excellent interpersonal and communication skills, and in-depth knowledge of global regulatory guidelines are essential for success. Proficiency in Microsoft Word, PowerPoint, and Excel, along with the ability to work effectively in a team-oriented environment, are also crucial requirements. The ideal candidate should be adaptable, capable of working under pressure, and able to deliver high-quality results within tight timelines. This position is based in Gurgaon, Haryana, India. Occasionally, you may be required to work across different time zones to fulfill job requirements.,
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
karnataka
On-site
As a KYC (Know Your Customer) Operations Auditor at PhonePe, you play a crucial role in ensuring adherence to regulatory requirements and internal policies concerning merchants" due diligence. Your primary responsibilities include conducting detailed audits of KYC processes and documentation to verify accuracy, completeness, and compliance with established standards. Meticulous attention to detail, strong analytical skills, and the ability to interpret and apply regulatory guidelines effectively are essential for success in this role. Your key responsibilities will involve conducting thorough audits of KYC verifications processed by the team, evaluating the accuracy and completeness of KYC information collected during merchant onboarding and reviews, and ensuring compliance with regulatory requirements, internal policies, and standard operating procedures. Additionally, you will monitor KYC processes and procedures to align with regulatory changes and internal guidelines, analyze trends in KYC data to identify risks, and recommend improvements to policies based on audit findings and best practices. You will be responsible for preparing detailed audit reports summarizing findings, conclusions, and recommendations, as well as communicating audit results clearly to management and stakeholders. Collaboration with KYC operations teams to address findings and implement corrective actions, providing training on regulatory requirements and audit best practices, and fostering a culture of compliance and continuous improvement within the KYC operations function are also part of your role. To be eligible for this position, you should have at least 2 years of experience in KYC operations, compliance, or audit within the financial services industry. A strong understanding of AML regulations, KYC processes, and customer due diligence requirements is necessary, along with excellent analytical skills, attention to detail, organizational capabilities, and proficiency in using audit tools and software for documentation review and reporting. Key competencies for success in this role include integrity, ethical conduct, analytical thinking, problem-solving skills, effective communication, interpersonal abilities, independence in work, teamwork, and adaptability to evolving regulatory requirements and industry trends. PhonePe values its employees and offers a range of benefits including insurance coverage, wellness programs, parental support, mobility benefits, retirement benefits, and other perks for full-time employees. Working at PhonePe provides a rewarding experience with opportunities for creativity, role expansion, and collaborative work environment. Join us at PhonePe and be a part of a dynamic team that values innovation and empowers you to make a meaningful impact!,
Posted 1 month ago
8.0 - 13.0 years
15 - 30 Lacs
Gurugram
Work from Office
Skillventory is mandated to hire AVP, Regulatory Compliance with a leading Health Insurance company for Gurgaon. Were looking for an AVP Regulatory Compliance to drive a culture of compliance, ensure regulatory adherence, and support governance across business functions. Location: Gurgaon Experience: Minimum 8+ years in regulatory compliance, preferably in insurance and Team Handling Must Qualification: Graduate/Postgraduate with relevant certifications (Law/CS/MBA preferred) Key Responsibilities: Ensure implementation of new laws & regulations across functions Review insurance products, marketing materials, and customer communications for regulatory compliance Audit internal processes (sales, claims, underwriting, operations, etc.) for compliance gaps Drive IRDAI reporting processes & timely submissions Develop compliance frameworks, internal controls, and documentation Guide business teams on regulatory and ethical standards Conduct compliance workshops and training Support the Head of Compliance on regulatory programs and governance initiatives To review training material, modules and manuals from compliance perspective. Contact Person: Name: Ravi Kumar Sharma Contact No.: 7489933146 (Whatsapp) Email: ravikumar.sharma@skillventory.com #Hiring #ComplianceJobs #IRDAI #HealthInsurance #RegulatoryCompliance #GurgaonJobs #AVPRole #InsuranceCareers
Posted 1 month ago
15.0 - 20.0 years
35 - 40 Lacs
Mumbai
Work from Office
Role & responsibilities Handled exposure preparation for the bank. Handled regulatory returns such as CRILC, NeSL, RBS, EDR, PSL and SLBC reporting, SIBC Handling and closure of audit observations Handled Capital adequacy calculation Various Internal and Management reporting/MIS including Board note submissions Handle statutory/Internal/RBI and concurrent audit as well as closure of audit/LFAR observations Support to all automation activities including discussion with vendor on finalization of BRD requirement, handling UAT and subsequently managing production run Support and Back up to Early warning signal system wherever required (Preferably) Support to stakeholders as per requirement of the job
Posted 1 month ago
3.0 - 7.0 years
0 Lacs
maharashtra
On-site
As an Internal Audit Review Officer, your primary responsibility is to review internal audit reports to ensure uniformity and parity across various audit areas, aligning with the scope and coverage of audits. You will work under the supervision of the Team Leader and the guidance of the Group Head to maintain the effectiveness of the Internal Audit function. Your responsibilities will include conducting quality checks of audit reports, conducting ad hoc reviews to achieve audit parity, and identifying areas for development or improvement. You will assist the team leader in preparing notes for the Board and Audit committee, coordinating the quarterly audit calendar, and collating data for external auditors and RBI inspectors. Additionally, you will assist in reviewing manpower budgeting, risk categorization, audit plans, policy manuals, and other departmental documents. Furthermore, you will be involved in various assignments and reviews as delegated by the Team Leader and Group Head. Maintaining coordination within the department and with other departments is essential for the seamless execution of tasks. Staying updated on regulatory guidelines and developments related to your role is crucial. To qualify for this role, you should have a Graduate or Post Graduate degree with effective communication and drafting skills, analytical abilities, and proficiency in MS Word, Excel, and PowerPoint. The ability to plan and execute audit plans, meet deadlines, and understand related areas of operations and RBI guidelines on banking operations will be advantageous for this position.,
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
maharashtra
On-site
As the responsible individual for monitoring operational and customer service related activities of the CPC, it is your duty to ensure adherence to reporting schedules and escalate matters to superiors for advice. It is crucial to ensure speedy resolution of customer queries and complaints in accordance with laid down procedures and Quality standards. In terms of business, your role involves monitoring the day-to-day processing and customer service activities related to CPC with the primary purpose of meeting service standards. Additionally, resolving customer queries/complaints and service-related issues are essential tasks. Maintaining data and statistics on the team's performance related to business standards, customer information, etc., is also part of your responsibilities. Regarding processes, you are required to provide Trade-related Services to Customers and meet turnaround times as per the Service Level Agreement and productivity standards. Ensuring strict compliance with internal procedures in line with the standards laid down as per DOI is imperative for smooth operations. In managing people and talent, organizing workflow to achieve maximum productivity, regularly monitoring the team's performance to improve efficiency, developing, training, motivating, and educating staff, as well as enhancing staff morale, are key aspects of your role. Risk management is a critical component of your responsibilities, involving monitoring all major risk issues and concentrations, directing remedial action where appropriate, ensuring adequate reporting to Risk Committees, and complying with internal operating procedures and Key Control Standards. Complete compliance with the Bank's data confidentiality policy at all times is mandatory. Governance plays a vital role in your role, requiring you to ensure compliance with all internal procedures, operational controls, and regulatory requirements. Additionally, preparing Returns (Group and Regulatory) and submitting them within agreed time schedules, complying with all policies and procedures related to money laundering prevention, Group Sanctions Procedures, Group Policies on KYC, and Group Code of Conduct are crucial tasks. Moreover, you are expected to ensure timely archival of documents, maintain records as per the Group policy, and prevent operating losses. Displaying exemplary conduct and living by the Group's Values and Code of Conduct, embedding the highest standards of ethics, including regulatory and business conduct, and collaborating effectively to identify, escalate, mitigate, and resolve risk, conduct, and compliance matters are part of your responsibility. The key stakeholders you will be interacting with include internal departments such as CB, CIB, BB, SME, FI, Treasury, IT, Technology, other Trade CPCs, CSG/CMS, as well as external entities like customers, personnel in RBI and other regulatory bodies, statutory/external auditors, counterparts in other banks, archival vendors, other vendors, and GBS. To excel in this role, you should possess skills in MS Office/Excel, Business Market Knowledge, Business Products, and processes, as well as Regulatory Guidelines. The ideal candidate is a Graduate with a proactive approach to work and a commitment to upholding the bank's values and code of conduct. Standard Chartered is an international bank dedicated to making a positive difference for clients, communities, and employees. If you are seeking a purpose-driven career with a bank that values diversity and inclusion, we invite you to join us. Together, we strive to drive commerce and prosperity through our unique diversity, living by our valued behaviors and brand promise. You can expect support for your wellbeing, continuous learning opportunities, and an inclusive environment where everyone can realize their full potential.,
Posted 1 month ago
0.0 - 3.0 years
0 - 0 Lacs
chennai, tamil nadu
On-site
The role in this Pharmaceutical & Life Sciences full-time job based in Chennai, Tamil Nadu, requires you to oversee the collection, validation, and processing of clinical trial data. You will be responsible for developing and implementing data management procedures for clinical trials, supporting the review of medical coding, and ensuring compliance with applicable regulations, protocols, and standard operating procedures in India. Your role will involve maintaining the highest data quality standards throughout the data lifecycle, from data collection to database lock. It is essential to stay updated on industry best practices, technological advancements, and regulatory requirements related to clinical data management. The preferred candidate for this position should hold certification in clinical data management (like CCDM) and possess knowledge of CRF design, MS Project, and analytical capabilities. Familiarity with CDISC standards and data interchange formats such as SDTM and ADaM is beneficial. Basic knowledge of regulatory guidelines like FDA/CFR, ICH/GCP, understanding of data privacy and protection regulations (e.g., GDPR), and effective communication and interpersonal skills are essential to collaborate effectively with other teams. This role offers the opportunity to contribute to the advancement of clinical data management practices and maintain high standards of data quality in compliance with regulations and protocols.,
Posted 1 month ago
1.0 - 5.0 years
0 Lacs
delhi
On-site
You will be working as a Zonal Manager Medical Affairs at Signutra, a global expert in medical nutrition. This full-time on-site role is based in Delhi, India, and you will be responsible for overseeing medical affairs activities in the north zone. Your key tasks will include liasoning with Key Opinion Leaders (KOLs), ensuring compliance with regulatory guidelines, and providing medical education on the product portfolio. You will also collaborate with medical professionals in various fields such as pediatrics, gynecology, diabetology, critical care, and oncology. To excel in this role, you should hold a Medical degree (MBBS) or relevant healthcare qualification, possess strong medical knowledge, and have a good network with KOLs. Experience in medical education initiatives, excellent communication and presentation skills, and the ability to work effectively in a team are essential for this position. Ideally, you should have 1-2 years of experience in the nutrition or healthcare industry. If you are passionate about medical nutrition and are looking for a challenging role where you can make a difference in people's lives, this opportunity at Signutra might be the perfect fit for you.,
Posted 1 month ago
5.0 - 9.0 years
0 Lacs
maharashtra
On-site
The KYC Role - Client Implementation position at Deutsche Bank, located in Mumbai, India, offers a unique opportunity to be part of a leading global bank that prioritizes long-term success, digital innovation, and integrity in serving its clients. As a member of the International Private Bank division, you will be contributing to the bank's success by handling key responsibilities related to client data collection, documentation, and maintenance. Key responsibilities of this role include conducting client due diligence, verifying client information, and categorizing client risk levels in compliance with regulatory requirements. You will also be responsible for understanding complex ownership structures, reviewing KYC files, and analyzing sources of wealth generation for clients. Effective communication and collaboration with various stakeholders, including the Front Office and Anti Financial Crime function, are essential to ensure transparency and improve turnaround times. The ideal candidate for this role should have a post-graduate or graduate degree in Finance, Business, or Economics, with a strong understanding of AML, KYC, and financial crimes regulations, preferably in the Wealth Management sector. Relevant experience in client onboarding processes and a proven track record of working effectively in global teams are key requirements. Additionally, the candidate should possess excellent communication skills, the ability to work independently and in a team environment, and experience with tools such as Appway, Avaloq, Lexis Nexis, and World Check. At Deutsche Bank, we offer a supportive environment that includes training and development opportunities, flexible working arrangements, coaching from experts, and a culture of continuous learning. We value diversity and inclusivity in our workplace and encourage applications from individuals from all backgrounds. To learn more about Deutsche Bank and our values, please visit our company website at https://www.db.com/company/company.htm. Join us in our mission to excel together, act responsibly, and celebrate the successes of our people as part of the Deutsche Bank Group.,
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
haryana
On-site
As part of ETASHA Society's Project AtmaNirbhar expansion to Greater NOIDA and Gurugram, we are in search of a dedicated and experienced BFSI Trainer to provide training and guidance to youth aspiring to work in the Banking, Financial Services, and Insurance sectors. Your main responsibility within the Vocational Training & Placement team will be to equip young individuals from underprivileged backgrounds with the necessary skills for employment in the organized sector. Your duties will include: - Conducting comprehensive training sessions covering various BFSI modules such as Banking basics, Insurance products, Mutual Funds, Financial Literacy, Customer Service, and Regulatory Guidelines (e.g., KYC, AML). - Administering pre- and post-assessments to assess the effectiveness of the training. - Creating an interactive and stimulating learning environment to enhance the learning experience. - Maintaining accurate training records, attendance, and reports. - Assisting trainees in exploring career opportunities and preparing them for the BFSI sector. - Collaborating with placement teams to facilitate a seamless transition to employment. If you possess the following qualifications and skills, you could be the ideal candidate for this role: - A degree in Finance, Commerce, or a related field at the Graduate/Postgraduate level. - At least 2-3 years of experience in BFSI operations or training. - Excellent communication and facilitation abilities. - The capacity to engage with individuals from diverse backgrounds. - Certification in BFSI training or NISM/NISM modules would be advantageous. To apply for this position, please visit our website at www.etashasociety.org and explore our social media platforms for more information. Interested candidates should submit a current resume to hr@etashasociety.org, including their email id, current address, current salary, 3 references, and availability to join if selected. Please indicate "BFSI Trainer" in the subject line of the email.,
Posted 1 month ago
3.0 - 7.0 years
0 Lacs
maharashtra
On-site
As a KYC Role - Client Implementation at Deutsche Bank located in Mumbai, India, you will play a crucial role in ensuring the adherence to regulatory requirements and client due diligence processes within the International Private Bank division. Your responsibilities will revolve around client data collection, documentation, and maintenance during new adoptions or periodic reviews. You will be required to conduct thorough due diligence to validate the correctness of documents and perform Know Your Client (KYC) verification checks. Your main tasks will include understanding complex ownership structures for various client types, conducting comprehensive reviews of KYC files to identify gaps and ensure compliance with regulatory standards, analyzing sources of wealth generation for clients, and managing work pipelines efficiently by liaising with different stakeholders. Additionally, you will be responsible for name screening to identify politically exposed persons and mitigate risks associated with financial crimes. To excel in this role, you should possess a Post-graduate/Graduate degree in Finance, Business, or Economics with a deep understanding of AML, KYC, financial crimes, and regulatory requirements, preferably in the Wealth Management sector. Your experience in client onboarding processes and periodic KYC reviews, particularly in the APAC region, will be highly valued. Strong communication skills, the ability to work independently and collaboratively, proactive problem-solving skills, and familiarity with tools like Appway, Avaloq, Lexis Nexis, and World Check are essential for success in this position. At Deutsche Bank, you will benefit from a supportive environment that offers training and development opportunities to enhance your skills, flexible working arrangements to maintain a work-life balance, coaching from experienced team members, and a culture of continuous learning. Join us at Deutsche Bank and be part of a diverse and inclusive work environment where we empower each other to excel every day, act responsibly, and collaborate for success. Visit our website for more information on our company culture, and together, let's drive growth and shape the future of our clients.,
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
navi mumbai, maharashtra
On-site
As an Executive - Application Lab at Azelis India, your main objective is to develop innovation through formulation, application, sampling, and technical support in the Personal Care and Home Care products industry. You will be responsible for formulating a wide range of products, conducting stability studies, ensuring regulatory compliance, and working on sustainable product concepts aligned with market trends. Your role will also involve providing technical support to customers, conducting product demonstrations, and collaborating with suppliers on new ingredient innovations. In addition, you will manage the HPC application development lab, handle lab operations, support CAPEX planning, and maintain technical documentation. You will be required to provide internal technical training, evaluate market intelligence, develop marketing strategies, and monitor competition activities in the market. The ideal candidate for this role should have a B. Tech or M.Sc. in Chemistry/ M.Tech/Chemical Technology/cosmetologist with a minimum of 2-5 years of experience in technical/formulation development. Strong communication and collaboration skills, a sense of ownership, drive, and excellent organizational abilities are essential for this position. Fluency in English is a must, and proficiency in other languages is a plus. Adherence to work culture and ethics is also expected. Please note that the job requirements may evolve based on business needs, and you will be expected to adapt to changes and perform any tasks for which you are trained.,
Posted 1 month ago
1.0 - 5.0 years
6 - 16 Lacs
Jaipur
Work from Office
Job Description Qualification Chartered Accountant (Professionally qualified) Relevant Experience 1-6 Yrs. Post Qualification Functional Competencies Handled Regulatory & Financial Reporting in Banking Industry. A sound knowledge of financial adjustments and its impact on the regulatory reporting Candidate who has worked for the Automation of the Regulatory Reporting in Banking Industry is preferred. Behavioral Competencies Bias for Action and Urgency, Hard Work and Detail Orientation Integrity, Simplicity and Humility, Nurture Talent Responsibly Entrepreneurial, Dramatic Growth, Industry Awareness Job Responsibilities Financial & Non-Financial Responsibilities Preparation and Finalization of Regulatory Returns related to Finance & Accounts Time-bound completion of return preparation and ensuring submission within due date Compilation of data for submission of reply to Regulator Develop notes for RBI Related provisions and impact thereof Timely submission of Replies to RBI/regulator
Posted 1 month ago
2.0 - 6.0 years
7 - 11 Lacs
Mumbai
Work from Office
About The Role : Job TitleKYC Role, AS LocationMumbai, India Role Description About Deutsche Bank: Deutsche Bank is the leading German bank with strong European roots and a global network. Were driving growth through our strong client franchise. Against a backdrop of increasing globalization in the world economy, Deutsche Bank is very well-positioned, with significant regional diversification and substantial revenue streams from all the major regions of the world. We serve our clients real economic needs in commercial banking, investment banking, private banking and asset management. We are investing heavily in digital technologies, prioritizing long term success over short-term gains, and serving society with ambition and integrity. All this means a career packed with opportunities to grow and the chance to shape the future of our clients. About the business division International Private Bank is one of the preeminent private banks in the Eurozone and for family entrepreneurs worldwide. It serves around 3.4 million clients, including private clients and small and medium-sized enterprises (SMEs) in Italy, Spain, Belgium and India, and wealth management clients from more than 80 locations in Germany, the rest of Europe, the Middle East and Africa (EMEA), Asia-Pacific and the Americas. The business has around 250 billion euros of assets under management and a combined revenue of approximately 3 billion euros. It offers high-net-worth (HNW) and ultra-high net-worth (UHNW) clients a broad range of traditional and alternative investment solutions, as well as comprehensive advice on all aspects of wealth management. Additionally, in Italy, Spain, Belgium and India it offers a comprehensive range of products including investment and insurance products, deposits, checking accounts, cards and other payment services as well as credit and business banking products. What well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities : As part of the Deutsche Bank IPB , we are seeking to hire qualified candidates to handle the following functions: Client Data Collection, Documentation & Maintenance as part of new adoption / during periodic reviews. Should also know the due diligence required to establish the correctness/validity of documents Know your client verification checks Risk categorization reviews for clients as per the regulatory requirements with knowledge of enhanced due diligence required while adopting High Risk clients Liaise with different stakeholders to manage work pipeline effectively Key responsibilities of this role would include: Ability to understand complex ownership structures especially for non-traditional WM clients such Charities, Foundation, Trusts, Private Equity Funds and also Private Investment Companies (PIC), Detailed initial review of KYC file, identifying gaps in the Front Office submissions and clearly articulating why the submitted files meet (or do not meet) KYC and regulatory requirements Understanding the various sources of wealth generation for the client and analysing the information Ensuring that cases are prioritised and managed effectively and consistently in line with the agreed process and deadlines Independent and proactive liaison with Front Office and Anti Financial Crime function to ensure full transparency and improve turn-around times Perform name screening of clients and related parties to identify politically exposed persons, sanctioned persons, adverse media and mitigate risks associated with financial crimes Escalate high priority client / business issues in a timely manner to protect the franchise and the client business Your skills and experience A Post-graduate/Graduate degree in Finance, Business or Economics with a deep understanding of AML, KYC, Financial crimes, and other regulatory requirements (preferably Wealth Management) is what we are looking in the ideal candidate. Due to the nature of the job you should have the following skill sets: Relevant experience in Client On-boarding processes/Periodic KYC review and requirements Proven track record as a strong contributor and able to work in virtual global teams and a matrix organisation Ability to work independently, as well as in a team environment, initiative driven and proactive approach, prioritizes multiple tasks, and meets strict deadlines Experience in documenting processes to comply with the regulatory guidelines; Excellent communication skills, (written and verbal) with an open minded approach and the ability to share information with stakeholders and team members Proactively communicate with front office on deficiencies and/or next steps of KYC requirement Experienced in using the following tools Appway, Avaloq, Lexis Nexis, World Check, RDC and Fircosoft How well support you
Posted 1 month ago
2.0 - 4.0 years
5 - 9 Lacs
Hyderabad
Work from Office
In conjunction with the Submission Manager, and use of technologies, simplify the end-to-end process for Clinical Trial documents, maintenance and submissions Prepare Clinical Trial Submission documents adhering to regulatory guidelines and ensuring consistency across all BMS programs Partners with the Submission Manager for the timing and creation of the submission documents, including CSR appendices, Financial Disclosure Tables, and related submissions documents Ensures documents are formatted appropriately and Submission Ready Compliant (SRC) In collaboration with out outsourced partners, creates site numbers for new and ongoing clinical trials Enters site milestones and regulatory approvals dates to maintain the quality health of the trail assigned to Ensures Drug shipment address are entered correctly, and feed to SAP to enable IP Supply to sites Performs a reconciliation of Veeva (eTMF/CTMS) to ensure accurate data is available and reflecting correctly Proactively analyzes and drives efficient problem solving within team's control Applies critical thinking, developing mitigation and resolution strategies, and promptly responding to action items Demonstrates thorough knowledge of relevant BMS SOPs and policies and the ability to provide timely guidance in their application to Protocol and/or Program teams Assesses operational feasibility using GCPs, ICH and regulatory legislation and guidelines as they apply to submission deliverables where applicable Demonstrates strong project management skills Demonstrates thorough knowledge of creation of documents, and the document management systems and requirements (e g Core Template) Demonstrate understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process Manages interactions with senior level multifunctional teams across the oncology portfolio, to drive the operations submission documents Other duties as assigned to support Clinical Trials Performs other tasks as assigned Experience Requirements 2-4 years of relevant experience in clinical trial documentation management or a Clinically related or relevant field Demonstrated knowledge of ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma Experience in the use of industry Clinical Trial Master File Systems or equivalent Experience with Veeva Vault Clinical preferred Experience with MS office suite, SharePoint, etc CTMS (Veeva Vault experience preferred), knowledge of portals, databases and other Clinical Trial enabling technologies Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process
Posted 1 month ago
6.0 - 11.0 years
25 - 35 Lacs
Gurugram
Hybrid
Regulatory Compliance Manager American Express Company is seeking a skilled Regulatory Change Management professional to join our Global Compliance & Ethics team. This role will support the proactive identification, assessment, and implementation of regulatory changes across the organization, ensuring that all business units adhere to evolving regulations. The ideal candidate will possess expertise in navigating the complex regulatory environment affecting financial services and will be adept at managing changes that impact our business operations worldwide. Responsibilities: Regulatory Monitoring and Change Management Manage a team of analysts responsible for continuously monitoring domestic and international regulatory developments to identify changes that impact American Express Utilize automated tools for horizon scanning and maintain an up-to-date understanding of new regulations, amendments, and repeals. Support Regulatory Change Management triggered by business and process updates to ensure compliance with policies and regulations to include communication and training efforts. Implement strategies for responding to regulatory changes across different business units and corporate functions. Lead the process and provide instruction supporting business impact analysis using established methodologies to evaluate the potential impact of regulatory changes on various business units prioritizing changes based on their complexity, urgency, and potential business impact. Support ongoing monitoring of risk standards and programs to drive compliance with legal, regulatory, and Corporate Policy requirements. Provide constructive and effective challenge to internal stakeholders (e.g. business lines, risk and local compliance) to ensure regulatory risks are adequately addressed and mitigated. Maintain and enhance the Regulatory Change and Inventory Management Framework, ensuring alignment with regulatory requirements. Global Legal Inventory Management Collaborate with legal professionals to update and maintain the global legal inventory system with new regulatory requirements. Provide oversight in mapping laws rules and regulations (LRR) to business processes, products, and services and ensure these LRR are effectively mapped to controls mitigating regulatory risks and ensuring compliance Identify opportunities for improving legal inventory management processes based on data insights, including technology enhancements or process optimization. Data Analysis and Reporting Interpret complex datasets related to new regulations, amendments, and enforcement actions to inform risk assessments and compliance strategies. Develop and track key performance indicators (KPIs) like compliance metrics and the status of regulatory change implementations across various business units to measure regulatory change management effectiveness. Regularly present findings to senior management with insights on performance against regulatory requirements. Coordinate with internal audit and assurance functions to ensure regulatory compliance. Qualifications: Bachelors degree in law, Finance, Business Administration or related field; advanced degree preferred. Minimum of 5 years of overall experience in Banking and Financial Services, of which a minimum of 2 years of experience in compliance or regulatory change management. Experience in using or maintaining a repository of laws/rules/regulations and their corresponding obligations (e.g., GRC platform) preferred. Intermediate skills in data analysis, reporting, and risk assessment, including the use of data visualization tools (e.g., Tableau, Power BI). Experience using generative artificial intelligence tools preferred. Professional regulatory compliance certification preferred. Excellent analytical skills with an ability to interpret complex legal documents. Demonstrated project management skills with attention to detail. Skills: Solid understanding of relevant general laws, regulations and standards (e.g., GDPR, Payment Services Directives, UK SMR) applicable to European Legal Entities and affecting risk management of large banks. Develops, implements, or assesses strategies, programs, policies, procedures and risk limits to manage the organizations exposure to Compliance risk. Develops and uses data analytics tools to assess compliance trends, identifies potential risks and monitors compliance-related performance, supporting proactive risk management and regulatory adherence. Analyzes complex situations, identifies patterns and draws meaningful conclusions to perform logical and well-structured evaluations. Excellent written and oral communication skills, with the ability to challenge, collaborate and influence, without direct authority Highly flexible and adaptable, able to deal with ambiguity and broad concepts A cultural awareness and excellent relationship building skills, with a track record that clearly demonstrates an ability to build lasting partnerships across local and remote teams. Compliance Language We back you with benefits that support your holistic well-being so you can be and deliver your best. This means caring for you and your loved ones' physical, financial, and mental health, as well as providing the flexibility you need to thrive personally and professionally: Competitive base salaries Bonus incentives Support for financial-well-being and retirement Comprehensive medical, dental, vision, life insurance, and disability benefits (depending on location) Flexible working model with hybrid, onsite or virtual arrangements depending on role and business need Generous paid parental leave policies (depending on your location) Free access to global on-site wellness centers staffed with nurses and doctors (depending on location) Free and confidential counseling support through our Healthy Minds program Career development and training opportunities American Express is an equal opportunity employer and makes employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, age, or any other status protected by law. Offer of employment with American Express is conditioned upon the successful completion of a background verification check, subject to applicable laws and regulations.
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
navi mumbai, maharashtra
On-site
As a Packaging Assistant in the chemical industry, you will be responsible for assisting with the packaging and labeling of chemical products. Your primary focus will be on ensuring compliance with safety and quality standards. This includes preparing products for shipment, maintaining packaging equipment, and adhering to regulatory guidelines to guarantee safe and efficient packaging processes. Your role will require you to work closely with the packaging team to meet production requirements and deadlines. Attention to detail is crucial to ensure that all products are correctly packaged and labeled. Additionally, you will play a key part in maintaining a clean and organized packaging area to support overall operational efficiency. To excel in this position, you should have a minimum qualification of Any Graduate and possess 2-4 years of relevant experience in packaging within the chemical industry. Strong communication skills and the ability to work effectively in a team are essential for success in this role. If you are looking for a challenging yet rewarding opportunity to contribute to the packaging operations of a chemical company while upholding safety and quality standards, this role could be the perfect fit for you.,
Posted 1 month ago
8.0 - 12.0 years
0 Lacs
karnataka
On-site
As a Biostatistics Manager at our organization, you will play a pivotal role in managing and supervising a team of statisticians and biostatisticians. Your responsibilities will include overseeing statistical analysis and reporting activities for clinical trials, providing guidance on study design, sample size estimation, and statistical methodologies, as well as collaborating with cross-functional teams to ensure timely and accurate deliverables while maintaining compliance with regulatory guidelines and industry standards. In this role, you will be required to manage and allocate resources within the biostatistics team, ensuring adherence to quality and regulatory standards in statistical analysis. You will also collaborate with project teams to develop statistical analysis plans, oversee the preparation of statistical deliverables for regulatory submissions, provide guidance on complex statistical issues and study interpretations, and foster a culture of continuous learning and professional development within the team. To qualify for this position, you should have a Master's degree or Ph.D. in Statistics, Biostatistics, or a related field, along with a minimum of 8-10 years of progressive experience in Biostatistics, including leadership roles, within the pharmaceutical, biotechnology, or CRO industry. You should possess extensive experience in statistical analysis and clinical trial research, strong leadership and management skills, excellent communication and presentation abilities, and the ability to collaborate effectively with cross-functional teams. Join us in our mission to make work meaningful together, where alternative thinking gives rise to innovative ideas and human-centric processes are created through teamwork, co-creation, and co-execution. At YouV, you can expect unparalleled exposure, valuable learning opportunities, and a positive work environment that will add great value to your career. Immerse yourself in our unique culture of warmth and positivity, where collaboration, open-door policies, and inclusivity are at the core of everything we do.,
Posted 1 month ago
1.0 - 3.0 years
5 - 10 Lacs
Hyderabad
Work from Office
Job Summary We are seeking a highly skilled Analytical Scientist to join our Research and Development team. The successful candidate will be responsible for developing, validating, and implementing analytical methods for the quantification and identification of genotoxic impurities in pharmaceutical products. This role will involve extensive use of chromatography techniques and adherence to regulatory standards. The ideal candidate should have a strong background in analytical chemistry, method development, and data analysis, with a keen eye for detail and a commitment to ensuring the highest quality standards. Roles & Responsibilities You will be responsible to review relevant Literature and stay updated with the latest research and scientific literature relevant to the field of genotoxic impurities and chromatography methods. You will be responsible to develop and optimize chromatography-based methods for accurately quantifying genotoxic impurities in various samples. You will be responsible to address regulatory deficiency queries concerning the analytical methods and data related to genotoxic impurities. You will be responsible to ensure the quality and accuracy of reference standards and working standards used in analytical testing and method development. You will be responsible to develop analytical methods, conduct validation studies to ensure the accuracy and reliability of the methods, and transfer validated methods to the Quality Control (QC) department. You will be responsible to prepare comprehensive reports documenting method development, validation results, and any forced degradation studies performed. You will be responsible to conduct forced degradation studies to identify potential impurities and establish their chemical nature and behaviour. You will be responsible to perform real-time analysis of samples during product development stages to ensure product quality and consistency. You will be responsible for compilation of Stability Data to assess the stability profile of the products under various conditions. You will be responsible to evaluate the effectiveness of the product development strategy and identify any cross-functional issues affecting the process. You will be responsible to identify and plan for the developmental needs of the product, considering factors such as scale-up and potential process improvements. You will be responsible to source and manage the procurement of necessary chemicals, solvents, columns, and other laboratory equipment. You will be responsible to ensure proper maintenance of laboratory equipment as per Good Laboratory Practices (GLP) standards to guarantee accurate and reliable results. You will be responsible to calibrate instruments as per the calibration schedule and strictly follow Standard Operating Procedures (SOPs) to maintain consistency and accuracy. You will be responsible to maintain a clean and organized work area, and ensure that the laboratory environment is controlled at the required temperature for optimal analytical conditions. You will be responsible to keep all relevant documents well-maintained and organized for easy access and compliance with internal and external auditing requirements. Qualification Educational qualification: Masters in Science/ Organic chemistry Minimum work experience: 4 years of experience in analytical method development Skills & attributes: Technical Skills Have work experience on Process scale up of Active Pharmaceutical Ingredients. Experience in Process Optimization (Manufacturing) Experience in the development and regular analysis in Wet analysis-IR, Ultra Violet, Moisture analysis, Chromatographic techniques Strong understanding of regulatory guidelines and industry standards related to pharmaceutical product development and analysis. Proven experience in method validation and documentation in compliance with regulatory requirements. Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/
Posted 1 month ago
5.0 - 9.0 years
0 Lacs
maharashtra
On-site
As a KYC VP/AVP at Deutsche Bank Wealth Management in Mumbai, India, you will play a crucial role in overseeing a team of KYC Analysts and ensuring efficient processing to provide a top-notch client experience. You will act as the main point of contact for senior Front Office sales officers, coordinate with various stakeholders, and deliver key performance metrics to senior business managers. Your responsibilities will also include handling complex ownership structures, conducting due diligence, performing client verification checks, and ensuring compliance with regulatory requirements. Additionally, you will be responsible for prioritizing cases, liaising with Front Office and Anti Financial Crime function, and escalating high priority client issues promptly. The ideal candidate for this role should hold a Post-graduate/Graduate degree in Finance, Business, or Economics and possess a deep understanding of AML, KYC, Financial crimes, and regulatory requirements, preferably in the Wealth Management sector. You should have relevant experience in Client On-boarding processes/Periodic KYC review, proven track record in managing teams under high pressure, excellent communication skills, and the ability to work independently as well as in a team environment. Familiarity with tools like Appway, Avaloq, Lexis Nexis, World Check, and experience in documenting processes to comply with regulatory guidelines will be advantageous. At Deutsche Bank, you will have access to comprehensive training and development opportunities, coaching from experts in your team, and a culture of continuous learning to support your career progression. The company promotes a positive, fair, and inclusive work environment where employees are encouraged to excel together every day. Join us at Deutsche Bank Group and be part of a team where success is shared and celebrated. Visit our company website for more information: https://www.db.com/company/company.html.,
Posted 1 month ago
3.0 - 5.0 years
7 - 10 Lacs
Pune
Work from Office
PayGlocal is a global payments company that fosters global commerce. Our suite of offerings facilitatescross-border payments and solve the challenges surrounding it through three main pillars - the business, the experience and the associated risk. Founded by finance veterans and experts, our understanding of merchant business, international business, security and regulatory standards help build impactful payment solutions. We partner with large enterprises and export merchants for seamless customer payment journeys. Be a part of lasting innovation - create new products, new processes and new standards. Join us to help us shape the future of payments. Position Summary We are seeking a passionate and driven Chargeback AM/ Manager to join our vibrant team. In this role, you will be the frontline champion, managing chargeback cases, analyzing disputes, gathering evidence, submitting disputes, resolving claims, and preventing future chargebacks. You will also collaborate with various teams and ensure compliance with industry regulations. If youre detail-oriented and are excited about the payments industry, we want to hear from you. What will you work on? Chargeback Management : Handling chargeback requests, investigating transaction details, and gathering necessary documentation to support disputes• Dispute Resolution: Working with merchants, banks, and internal teams to resolve disputes related to chargebacks. • Compliance: Ensuring all chargeback processes adhere to relevant regulations and card network rules. • Reporting and Analysis: Generating reports on chargeback trends, analyzing data to identify patterns, and providing insights for improvement. • Communication: Maintaining clear and timely communication with customers, internal teams, and external partners Required Qualifications: 3-5 years of relevant experience in Chargeback management, dispute resolution. Preferable experience in Domestic UPI dispute handling process.• Understanding of payment processing, card network rules, and relevant regulations.• Ability to analyze data, identify trends, and draw conclusions• Strong organizational skills with the ability to manage and prioritize tasks effectively.• Ability to work effectively with other teams and departments.
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
karnataka
On-site
As a Medical Writer with our dynamic team, you will utilize your expertise in writing, editing, and reviewing scientific and medical content. Your primary responsibility will involve transforming intricate medical data and research findings into clear, accurate, and engaging documents suitable for various audiences, including healthcare professionals, regulatory bodies, and the general public. You will be expected to develop, write, and edit a diverse range of documents such as clinical study reports, regulatory submission documents, peer-reviewed publications, and educational materials. Your role will also involve generating high-quality manuscripts, abstracts, posters, and presentations for scientific conferences, journals, and other platforms. Collaboration is key in this role as you will work closely with researchers, clinicians, regulatory affairs professionals, and other stakeholders to ensure that all content aligns with regulatory standards, maintains scientific accuracy, and supports corporate objectives. Additionally, you will be responsible for preparing and revising documents for regulatory submissions, ensuring compliance with guidelines from regulatory bodies such as FDA, EMA, and ICH. Your tasks will also include conducting literature searches, reviewing existing medical research, and ensuring the accuracy and relevance of information to support content development. Quality assurance is crucial as you will be editing and proofreading content for clarity, consistency, accuracy, grammar, and adherence to style guides. Project management skills are essential as you will be managing timelines for multiple projects to ensure timely and efficient completion of tasks. Compliance with medical, ethical, and regulatory standards is a core requirement for this role. To qualify for this position, you should hold a degree in BAMS, BDS, MBBS, or Pharm D, along with a minimum of 2 years of experience in medical writing, medical coding, or a related field. Experience with regulatory documents is highly preferred. A strong understanding of clinical research, medical terminology, and regulatory guidelines is essential. Proficiency in Microsoft Office Suite, reference management software, and medical writing software is required. Excellent written and verbal communication skills are essential, with the ability to convey complex information clearly and concisely. Strong attention to detail, collaboration skills, and the capability to work independently and as part of a team in a fast-paced environment are also necessary. Exceptional command of the English language is required, and knowledge of additional languages is a plus. Desirable skills for this role include experience with writing for regulatory agencies, familiarity with scientific publishing and journal submission processes, knowledge of Good Clinical Practice (GCP), and experience with statistical analysis and interpretation of clinical data. This is a full-time, permanent position with benefits including provided food, health insurance, and Provident Fund. The work schedule is a day shift with a fixed location in person. The application deadline is 31/07/2025.,
Posted 1 month ago
5.0 - 9.0 years
0 Lacs
anand, gujarat
On-site
As an HR & IR Business Partner at our manufacturing plant located in Vasad (Gujarat), near Vadodara & Anand, you will play a crucial role in leading People & Industrial Relations initiatives. Working closely with leadership, your main responsibilities will include managing employee relations, grievance redressal, and IR strategies. Your key focus will be to build engagement mechanisms that promote an open and motivated workforce, as well as partnering with external stakeholders to address conflicts and labor issues effectively. Additionally, you will be responsible for driving succession planning, retention programs, and skill-building initiatives within the organization while ensuring compliance with labor laws and regulatory guidelines. To be successful in this role, you should possess an MBA/PG in HR or Industrial Relations along with at least 5 years of experience in manufacturing HR & IR roles. Strong negotiation, communication, and stakeholder management skills are essential for effectively carrying out the responsibilities of this position. If you believe you have the required qualifications and experience, we encourage you to share your updated CV with us at Liltesh.sharma@upgrad.com.,
Posted 1 month ago
5.0 - 9.0 years
0 Lacs
maharashtra
On-site
As the Audit Team Leader, your main responsibility is to lead the team and conduct audits of centralised departments/functions. You will be in charge of executing the audit calendar and assignments, which includes allocating audits based on expertise and man-days available, monitoring scope and quality of reviews, risk grading, forming opinions, finalising audits, conducting discussions, and closing audits within specified timelines. This also involves visiting branches/units and releasing reports promptly. You will lead the team in conducting audits of departments with centralised/regional operations across various business functions, thematic audits, management audits, spot audits, user acceptance tests, etc. It is essential to conduct audits in compliance with regulatory guidelines, internal policies of the organization, and standard audit procedures. An important aspect of your role is to ensure timely, accurate, concise, and effective documentation of audit reports highlighting exceptions observed during the audit. You will critically review existing processes and procedures in respective areas, identifying areas for improvement to enhance controls and streamline process flows. Additionally, you will provide support during RBI inspections, RBS requirements, ACB reporting, investigations, and serve as a trainer for the Training Committee. Your role also involves tracking and identifying revenue leakages, proposing measures/processes to address them, and ensuring qualitative and effective performance in all audit areas. Assigning risks to audit observations, determining audit ratings for each assignment, recommending process changes when necessary, tracking audit observations, reviewing responses/compliance, updating audit databases, and closing audit files are integral parts of your responsibilities. Lastly, you will lead and guide/groom team members to ensure their effective performance and development within the audit team.,
Posted 1 month ago
7.0 - 12.0 years
15 - 27 Lacs
Mumbai, Navi Mumbai, Mumbai (All Areas)
Work from Office
Role & responsibilities About the Role The official is responsible for overseeing compliance risk management for Retail Lending and Payments. Key Responsibilities - Regulatory adherence / monitoring implementation: Assessment of applicable regulatory guidelines and identifying the actions emanating from these guidelines. Ensuring that changes in applicable regulatory guidelines are promptly disseminated, along with actionable to the concerned business units / departments for implementation. Driving timely implementation of regulatory changes across various business Advisory / Consultative Role: Driving an effective compliance management program through formulation of policies, review of relevant MIS and timely escalation of issues. Advising business units on processes / controls from compliance standpoint to ensure adherence to the regulatory guidelines. Engaging with regulatory authorities to facilitate discussions and/or seek specific guidance on critical matters. Reviewing new products / change in product features, to be in alignment with the regulatory guidelines. Review of policies / internal guidelines from compliance perspective, before being disseminated to the units for implementation. Assisting with regulatory enquiries / examinations Monitoring / Assessment: Consistently monitoring the effectiveness of processes / controls through Key Compliance Indicators (KCIs), compliance testing. Identifying non-compliance / breaches through various sources like RBI RAR, Internal Audit, Operational Risk Reports, etc., advising business in carrying out root cause analysis and on remedial action plan. Conducting annual compliance risk assessment and identify critical units / focus areas for mitigation of compliance risk. Regular meetings with the business unit heads to discuss compliance matters / open issues. Assisting in development and administration of compliance training to business units. Reporting to Board / ACB / Governance forums: Reporting and Updating the Board / Audit Committee of the Board on important regulations and non- compliances / breaches observed in various areas. Participating in governance forums to advise business from compliance standpoint Preferred candidate profile Chartered Accountant, Company Secretary, MBA / Postgraduate with banking background with job experience of 6-12 years.
Posted 1 month ago
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