156 Ctd Jobs

Analysts engage in risk, compliance, and financial crimes projects to serve Promontory clients within the banking and finance industry – helping them meet and exceed regulatory expectations. Analysts are expected to positively contribute to Promontory’s success in a variety of areas, including BSA, anti-money laundering surveillance and reporting assistance, OFAC sanctions compliance, and other areas relevant to today’s heightened regulatory climate. Analysts must possess excellent writing, research, analytical, and critical thinking skills, and other applicable experience that leads to success in the role, such as strong work ethic and natural curiosity. Analysts must be able to judiciously analyze, assess, and write clearly and concisely. The nature of this work requires individuals to be flexible, learn new skills, work within time constraints, and meet uncompromising quality requirements and production expectations while working closely with others in a dynamic team environment. Apply logic and strong reasoning skills to conduct research for case analysis. Use sound decision-making skills to make recommendations based on research results. Compose comprehensive supporting narratives Interpret and apply project policies and procedures to direct work. Maintain high work product quality as outlined by each project specifications. Ensure work adheres to defined engagement policies and procedures Manage work efficiently to meet production goals and project deliverables. Contribute to developing individual and project goals and execute on tactical strategies for goal attainment. Required education Bachelor's Degree Preferred education Master's Degree Required technical and professional expertise 1+ year prior AML experience REQUIRED. Compliance experience at a financial institution is STRONGLY PREFERRED. Retail banking experience is PREFERRED. The ability to work independently, take initiative, and able to adapt to change. Ability to quickly understand and maintain current know3ledge of banking regulations, concepts, and issues. Quickly learn new applications and client systems to conduct research. Exercise sound judgment and observe the highest degree of confidentiality. Adept at multi-tasking and meeting deadlines in high-pressure environment. Results oriented team player with strong initiative and flexibility. Strong analytical and problem-solving abilities. Superior writing skills with the ability to convey ideas clearly and succinctly. Exemplary customer service towards both internal and external parties.

Job Area: Finance & Accounting Group, Finance & Accounting Group > Global Accounting Ops Center General Summary: Job Overview The EMEA Payroll Staff will support the Qualcomm EMEA Payroll function, its processes, and internal or external relationships with General Accounting, Human Resources, Legal, Benefits, Employee Relations, Stock Programs, IT, Tax Auditors, ADP, and other related entities. This position will be responsible for developing, implementing, and maintaining processes that will contribute to efficient payroll processing for 5,000+ employees across multiple EMEA countries. This position will report to the Payroll Manager, located in Hyderabad, and will be responsible for coaching and guiding junior team members. The ideal candidate for this position is a people manager with 12+ years of experience, including a minimum of 3+ years in people management. We are looking for an individual with demonstrated experience in multi-country accurate and timely payroll processes who can effectively communicate with a global team. Responsibilities Own the operations of EMEA payroll for countries such as the UK, Ireland, France, Sweden, Netherlands, etc. This may include directly managing the EMEA payroll teams processing of monthly payroll, including ESPP and RSU stock reporting, benefits, tax, and social insurance requirements and reporting Timely review and first approval of multiple monthly payrolls for the accuracy, completeness and compliance Ensure compliance in operational controls around critical payroll processes such as new hires, terminations, and one-time payments Collaborate closely with the global payroll team and payroll partners on payroll processing, department initiatives, and projects Analyze payroll processes and controls, identify opportunities for improvement, and ensure global process consistency where applicable Liaise with external auditors and manage payroll-related audits Perform other special projects and analyses as directed by management Keep an eye on payroll KPIs and lead from front to improve them Minimum Qualifications Bachelors degree or equivalent foundation degree Certified Payroll Professional certification- good to have 10-12 years of total EMEA country payroll experience Demonstrable experience of mentoring junior team members Experience working in a multinational organization Expert skills with ADP Global View and Workday Excellent understanding of payroll systems, data workflows, and root cause analysis Current knowledge of applicable tax, social security, and other compliance requirements across multiple EMEA countries Fluent in spoken and written English Knowledge of taxable and non-taxable earnings and expenses; payroll tax laws and complex employee benefit programs impacting payroll Proven experience in designing and implementing processes, controls, and systems Solid understanding of equity-related transactions (RSU, ESPP gain) Ability to handle multiple tasks, set priorities, and meet deadlines in a high-volume, fast-paced environment High degree of accuracy, attention to detail & strong Excel and numerical skills Strong knowledge of payroll accounting and reconciliations Outstanding written and oral communication, organizational, and leadership skills Preferred Qualifications Masters degree in accounting Proficiency in French or any other European language Hands-on payroll knowledge of France, Sweden, and UK payrolls Any payroll certification is a plus End-to-end project experience with ADP Global View implementation Exposure or experience in mergers and acquisitions Minimum Qualifications: Bachelor's degree. 6+ years of Finance, Accounting, or related work experience.*Completed advanced degrees in a relevant field may be substituted for up to two years (Masters = one year, Doctorate = two years) of work experience. Job Overview The EMEA Payroll Staff will support the Qualcomm EMEA Payroll function, its processes, and internal or external relationships with General Accounting, Human Resources, Legal, Benefits, Employee Relations, Stock Programs, IT, Tax Auditors, ADP, and other related entities. This position will be responsible for developing, implementing, and maintaining processes that will contribute to efficient payroll processing for 5,000+ employees across multiple EMEA countries. This position will report to the Payroll Manager, located in Hyderabad, and will be responsible for coaching and guiding junior team members. The ideal candidate for this position is a people manager with 12+ years of experience, including a minimum of 3+ years in people management. We are looking for an individual with demonstrated experience in multi-country accurate and timely payroll processes who can effectively communicate with a global team. Responsibilities Own the operations of EMEA payroll for countries such as the UK, Ireland, France, Sweden, Netherlands, etc. This may include directly managing the EMEA payroll teams processing of monthly payroll, including ESPP and RSU stock reporting, benefits, tax, and social insurance requirements and reporting Timely review and first approval of multiple monthly payrolls for the accuracy, completeness and compliance Ensure compliance in operational controls around critical payroll processes such as new hires, terminations, and one-time payments Collaborate closely with the global payroll team and payroll partners on payroll processing, department initiatives, and projects Analyze payroll processes and controls, identify opportunities for improvement, and ensure global process consistency where applicable Liaise with external auditors and manage payroll-related audits Perform other special projects and analyses as directed by management Keep an eye on payroll KPIs and lead from front to improve them Minimum Qualifications Bachelors degree or equivalent foundation degree Certified Payroll Professional certification- good to have 10-12 years of total EMEA country payroll experience Demonstrable experience of mentoring junior team members Experience working in a multinational organization Expert skills with ADP Global View and Workday Excellent understanding of payroll systems, data workflows, and root cause analysis Current knowledge of applicable tax, social security, and other compliance requirements across multiple EMEA countries Fluent in spoken and written English Knowledge of taxable and non-taxable earnings and expenses; payroll tax laws and complex employee benefit programs impacting payroll Proven experience in designing and implementing processes, controls, and systems Solid understanding of equity-related transactions (RSU, ESPP gain) Ability to handle multiple tasks, set priorities, and meet deadlines in a high-volume, fast-paced environment High degree of accuracy, attention to detail & strong Excel and numerical skills Strong knowledge of payroll accounting and reconciliations Outstanding written and oral communication, organizational, and leadership skills Preferred Qualifications Masters degree in accounting Proficiency in French or any other European language Hands-on payroll knowledge of France, Sweden, and UK payrolls Any payroll certification is a plus End-to-end project experience with ADP Global View implementation Exposure or experience in mergers and acquisitions Applicants Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, rest assured that Qualcomm is committed to providing an accessible process. You may e-mail or call Qualcomm's toll-free number found . Qualcomm expects its employees to abide by all applicable policies and procedures, including but not limited to security and other requirements regarding protection of Company confidential information and other confidential and/or proprietary information, to the extent those requirements are permissible under applicable law. To all Staffing and Recruiting Agencies Please do not forward resumes to our jobs alias, Qualcomm employees or any other company location. Qualcomm is not responsible for any fees related to unsolicited resumes/applications. If you would like more information about this role, please contact .

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Data Review Associate in Mumbai, India to join our Global Clinical Coding & Support team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous nursing expertise and can develop and grow your career even further, then this is the opportunity for you! Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Comprehensive manual review of clinical data collected in trials Development of clinical review guidelines for specific therapeutic areas Interface with Data Management team to assure query resolution Seeking specialization in following therapeutic areas: Oncology Hematology Infectious Disease Endocrinology Metabolic disorders Qualifications Bachelor’s Degree in Nursing / Medicine, or more advanced clinical degree Professional / or Post-Qualification Nursing experience, preferably in Oncology and Hematology background General knowledge of clinical trial processes and/or experience working with clinical data Experience with using MedDRA and WHO Drug dictionaries will be a plus. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Preparation of DMFs for different markets in CTD and eCTD formats. Coordination with cross-functional dept to manage the documents. Supporting marketing team & QC/QA/R&D in various capacity. Preparation of Declarations and other supporting docs.

We are looking for a skilled professional with 3 to 7 years of experience to join our team as an Area Receivable Manager - MF in Equitas Small Finance Bank Ltd, located in the BFSI industry. Roles and Responsibility Manage and oversee the receivables process for efficient cash flow. Develop and implement strategies to reduce delinquencies and improve collection rates. Collaborate with cross-functional teams to resolve customer issues and enhance service quality. Analyze financial data to identify trends and areas for improvement in the receivables process. Ensure compliance with regulatory requirements and internal policies. Lead and motivate a team to achieve business objectives and goals. Job Minimum 3 years of experience in a related field, preferably in BFSI or finance. Strong knowledge of financial regulations and laws governing the BFSI sector. Excellent leadership and management skills, with the ability to motivate teams. Strong analytical and problem-solving skills, with attention to detail. Effective communication and interpersonal skills, enabling strong relationships with customers and stakeholders. Ability to work in a fast-paced environment and adapt to changing priorities.

We are looking for a highly skilled and experienced Branch Receivable Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2-5 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the daily operations of the branch's receivables. Develop and implement strategies to improve collection efficiency and reduce delinquencies. Collaborate with internal teams to resolve customer complaints and issues related to payments. Analyze financial data to identify trends and areas for improvement in the bank's receivables. Ensure compliance with regulatory requirements and company policies. Maintain accurate records and reports of all transactions and interactions with customers. Job Requirements Strong knowledge of banking regulations and laws. Excellent communication and interpersonal skills. Ability to work effectively in a fast-paced environment and meet deadlines. Proficient in using computer software applications and systems. Strong analytical and problem-solving skills. Ability to maintain confidentiality and handle sensitive information. Experience working in a similar role within the BFSI industry is preferred.

We are looking for a skilled Branch Receivable Manager to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 5-10 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the branch's receivable portfolio, ensuring timely payments and minimizing bad debts. Develop and implement strategies to improve cash flow and reduce receivables. Collaborate with cross-functional teams to resolve customer complaints and issues. Analyze financial data to identify trends and areas for improvement in receivables management. Ensure compliance with regulatory requirements and internal policies related to receivables. Lead and motivate a team of professionals to achieve business objectives. Job Requirements Strong knowledge of accounting principles, financial regulations, and banking practices. Excellent communication, leadership, and problem-solving skills. Ability to work in a fast-paced environment and meet deadlines. Proficiency in financial software and systems. Strong analytical and decision-making skills. Experience in managing and motivating a team of professionals.

The Senior Associate, Global Submission Management – International, 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 international (ex-US and Canada) 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 EU, JAPAC, GCC, ZA

What you will do Let’s do this. Let’s change the world. 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 submission execution for Amgen products across phases of development, modality, and countries. In this vital role you 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 submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket 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 submissions and related communications in the document management system Initiate and maintain CMC product 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 What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR Master’s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Experience managing or overing staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development 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 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.

Let’s do this. Let’s change the world. In this vital role you will report into the Regulatory Compliance Team lead. The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level. Roles & Responsibilities: Key responsibilities of the Regulatory Manager include: Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope. Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system. Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies Provides expertise and guidance to interdepartmental and cross-functional teams Coaches and support junior regulatory staff’s career development Identifies and implements process improvements for the change management process What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree and 4 to 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Diploma and 10 to 12 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Degree in Life Science discipline Regulatory CMC specific knowledge & experience Understanding and application of principles, concepts, theories and standards of scientific/technical field Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry 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

Roles and Responsibilities Should Have Formulation Experience. 1. Responsible for product registration in ROW (AFRICA, ANZ, ASIA, LATAM, CIS &, MENA). 2. Responsible and involving in the regulatory audits and coordinating with the auditors/customers. 3. Preparation, compilation and review of dossiers for RoW region in CTD /country specific format. 4. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. 5. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. 6. Responding to queries with in the time lines received from client/agency. 7. Preparation of check list as per country specific requirements in RoW region. 8. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in RoW region. 9. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. 10. Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. 11. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. 12. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Desired Candidate Profile Should Have Regulatory Affairs Relevant Experience Perks and Benefits

Role & responsibilities : Lead Regulatory Affairs department. Should be well versed with submission of Document in CTD/ACTD Format for Regulatory & ROW Market. Should be able to handle team. Preferred candidate profile Reputed Pharma background.

: Job Title - Non Party Reference Data, NCT Location - Bangalore, India Role Description: The Senior Analyst will be responsible for completion of day-to-day activity for IRDS process. The primary function of the role is to work within Reference Data Space which includes Reference/static data setup and maintenance, Data quality queries/ issues received from client, Exception management, Reconciliation of data between systems, monitoring the data quality report and to ensure accurate, timely and quality delivery of services provided within a risk-free controlled environment, to ensure Deutsche Banks overall client satisfaction. Further daily/weekly/Monthly MIS, client escalation, other reports and ad-hoc work would also be handled 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 Should have a very good knowledge of Reference Data Services (Financial Instruments) To work on all the assigned tasks and ensure the delivery is done as per KPI. Should have SQL Knowledge (advantage). To act as an SME of the process. To be able to train the new Joiner as and when required. Own and maintain KOP of the respective process. Ensure completion / adherence of activity as per standard procedure/key operating procedure. Ensure quality/quantity of processing is maintained as per the SLA. Ensure Daily/Weekly/Monthly MIS is published. To handle escalations from client or escalate issues in time, to the TM level, to avoid any adverse impact on the business. Ensure teamwork culture is practiced. Ensure proper back-ups created and assist other teams during contingencies (Staff shortage, high volumes etc.,) Your skills and experience Skills Needs to be a self-starter with significant ability to undertake initiatives. Strong interpersonal / good negotiations skills are required, Follow through skills, Effective communication skills, Ability to confidently handle internal clients and open for shifts (APAC/EMEA/NY Education/ Qualification Graduates with good academic records Experience of 4-7 years with functional RDS background Having technical (SQL basic) would be an added advantage. Proven problem-solving skills. 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.

Prepare, submit regulatory dossiers for new product registrations Coordinate and manage the submission of regulatory documents Facilitate communication with health authorities, responding to queries Required Candidate profile M. Pharm (Female Candidate Preferred) 1 year of experience in Regulatory Affairs in Pharmaceutical Formulations unit desired. Excellent communication skills.

Skill required: Contract Management - Contract management Designation: Contracting Counsel Associate Manager Qualifications: Any Graduation Years of Experience: 10 to 14 years What would you do? Legal Buyside Contracting Role Summary – To provide comprehensive legal support to Procurement and Business teams which includes drafting, reviewing, negotiation and execution of contracts, NDA's and other documents relevant to procurement support in accordance with company policies and procedures, applicable laws and customer requirements. Provide advisory support to procurement and business teams by driving the creation of templates, standardize the templates, maintain and continuously improve the standard contracts templates and procedures for complex buyside deals in accordance with changing laws and company policies. Develop specialized subject-matter expertise in support area to seamlessly address any potential risks or issues.Complexity: Requires identifying and assessing complex problems for area of responsibility. Creates solutions in situations in which analysis requires an in-depth evaluation of variable factors. Requires adherence to strategic direction set by senior management when establishing near-term goals. Interaction is with senior management of the team, internal stakeholders third party vendors, contractors subcontractors etc., involving matters that may require acceptance of an alternate approach..Authority:Some latitude in decision-making. Acts independently to determine methods and procedures on new assignments.Impact or Decision Impact:Decisions have a major day to day impact on area of responsibility.Scope:Manages large - medium sized teams and/or work efforts (if in an individual contributor role).Relationships:Supervises:?Team members providing services on a process/project or account/portfolio of accountsExternal Relationships:?Procurement, Business Executives, Contract Management, Outside counsels, Vendors, Corporate Function related stakeholders like HR, Workplace etc. What are we looking for? Bachelor's degree in LawCertifications and Membership:?Contract related global professional certification considered a plusWork Experience:?Minimum of 5 to 15 years of experience at law firm or as in-house counsel and/or in legal outsourcingKnowledge and Skill Requirements: Expert level understanding of both commercial and legal contractual risks and displays ability to provide business-oriented legal advice Fluent in English with strong oral and written skills Experience in managing end-to-end projects and teams on function specific processes and/or areas, work with internal and external teams, and understands delivery requirements Demonstrate excellent interpersonal skills, is detail-oriented, has sound judgement, is adaptable, demonstrate promptness, accuracy, and consistency with the activities supported, and drive tasks to closure, has strong time management, prioritization, organizational skills Build trust-based relationships by delivering on commitments, ability to work under pressure, with exposure to senior management Effectively manage priorities and stakeholder expectations Able to effectively influence senior management. Good understanding of Accenture offerings and function specific services performed, very good understanding of commercial agreements, legal and compliance fundamentals, corporate business practices, and contracting regulations Comfortable with technology and has experience in the use of tools & databasesBehaviours and Attributes: Open to work with and understand cross-cultures and locations throughout Accenture global organization Understand the value of diversity and recognize the strengths that different styles, innovative perspectives and experiences bring to Accenture Demonstrate inclusion and respect for all individuals regardless of gender, race, ethnicity, religion, belief, age, disability, culture, social status and/or sexuality Leader as well as team player, collaborative and persuasive; able to work well with executives and non-executives.Work Requirements:?Travel may be required Fluency in English (and other language, depending on geography supported) with very strong oral and written communication skills. Roles and Responsibilities: Generic Responsibilities Qualifications Any Graduation

Dossier Power House

Role & responsibilities Responsible for Drug Master Filing submissions to various regulatory agencies like USFDA, European Agencies, Brazil, and other semi-regulatory countries. Review and submission of Response to queries raised on DMF by USFDA, and other agencies. Review and submission of Amendments and revisions of Drug Master Files. Review and ensuring the regulatory compliance of CMC information and manufacturing facilities of advanced intermediated through regular visits, which are intended to submit to regulatory markets. Evaluation of cost reductions processes in regulatory point of view and submitting to different regulatory agencies. Review of OOS, BPR, process validation, and other quality assurance documents required for regulatory submissions. Markets Handled: USA, Europe, Canada, Brazil, other ROW etc. Preferred Candidate Candidate must have experience working in Regulatory Affairs in Pharma API Industry.

Job Title: Senior Regulatory Publishing Specialist Responsibilities:Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets.eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with regulatory standards. Submission Build Activities: Execute submission build activities, including creating inter-document links, conducting quality checks, validating compiled submissions, and ensuring timely dispatch.Collaboration with RA - Ops Team: Coordinate and engage with the Regulatory Affairs Operations team to facilitate on-time submissions and publishing tasks. Manufacturing Document Review: Review critical manufacturing documents such as MFC, BMR, process validation Protocol/report, stability protocol/report, sampling protocol, process validation protocol, and PDR.Response to Agency's Queries: Prepare and review responses to regulatory agencies' queries, ensuring timely submission within stipulated deadlines.Regulatory Submissions Development: Develop and deliver comprehensive regulatory submissions within agreed-upon timeframes, providing crucial regulatory support to project teams for assigned projects. Qualifications:Education: Bachelor's/Master's Degree (preferably in B Pharm/ M Pharm) or Any Life Science field. Experience: Minimum 3-6 years of hands-on experience within the CRO/Biotech/Biopharma industry. Expertise: Demonstrated expertise in gap analysis, publishing, and knowledge of CTD compilation.Communication Skills: Excellent communication and interpersonal skills, both written and spoken, with the ability to effectively interact with sponsors and internal stakeholders at all levels. Location - Madhapur, Hyderabad, Telangana, India 500081

We are seeking an experienced Regulatory Affairs professional to support and manage the regulatory lifecycle of oral solid dosage (OSD) products across key global markets, including the EU, USA, and RoW.

Regulatory Affairs Job Opportunity! Desired Experience : 3- 15 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Senior Manager/ Manager/ Deputy Manager/ Assistant Manager/ Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Job Responsibilities: Responsible for Regulatory submission to Indian NRA, Emerging Markets, Regulated Markets and World Health Organization. Experienced in handling, management and expansion of product portfolios, markets/ territories. Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC. Expertise in preparation, compilation and submission of Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, Export NoC, etc., but not limited) Well versed with Indian NRA submission portals, IBKP, SUGAM, NSWS, ODLS/ ONDLS, etc. Author, review and compilation of Regulatory Packages like Briefing documents, Scientific package, Pre-IND packages, Clinical Trial, Expedited request, Pre-qualifications, etc. Author, review, compile and submission of Marketing Authorization Applications (CTD/ ACTD/ eCTD) in India, Emerging Markets, Regulated Markets and Vaccine Prequalification Dossier to WHO. Application for Post Approval Change(s), Variations and Comparability packages Author, review and submission of responses to India, EM, WHO and Regulated markets.. Hands-on experience with MS office tools, PDF, Track Wise, DMS, Veeva Vault, Lorenz/ Pharma ready, etc.. Handling the Health Agency audits for India, EM, Regulated and WHO inspections Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution, Marketing and various teams (Internal & External). Review of Artworks (Labels and Package Insert) and Pack Profiles. Any other regulatory support required by the organization per submission need. Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for "Regulatory Affairs"

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Search Strategy, AMV, CDP, BE Study. Country Experience Required: Uzbekistan, Kazakhstan, Azerbaijan, Turkmenistan and Tajikistan Dosage Form Experience Required: Tablets, Capsules, Oral Powder (Sachet), External Preparation (Gel & Cream), Injections, Infusions, Suspension, Syrup, Oral Drops, Suppositories.

The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level. Roles & Responsibilities: Key responsibilities of the Regulatory Sr Associate include: Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope. Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system. Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a type of person with these qualifications. Basic Qualifications: Master’s degree OR Bachelor’s degree and 2 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Associate’s degree and 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Diploma and 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Degree in Life Science discipline Regulatory CMC specific knowledge & experience Understanding and application of principles, concepts, theories and standards of scientific/technical field Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry

Medical Review Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will provide medical review of individual case safety reports (ICSRs) in support of safety surveillance for Amgen products To support global individual case safety reports regulatory reporting compliance To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT) To implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports To act as a significant point of contact for Case Management on medical content of ICSRs Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports Support MSRT product lead if assigned Execute ICSR case escalation as appropriate Execute appropriate case follow up per SOPs Support medical coding conventions, and systematic process improvements for ICSR medical review Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems. Support MSRT Product Lead activities for the list of expected terms in the auto label tool Support Quality Assurance of ICSR medical review (if applicable) Support training to vendor staff (if applicable) on ICSR medical review Mentor junior medical reviewers. Participate in Safety Assessment Team (SAT) (if applicable) Provide input on teams for interdepartmental and cross-functional initiatives including process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review Perform other duties related to the position as necessary as defined in SOPs or as requested by his/her supervisor Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: MD/DO or international equivalent AND 3 years of related drug safety experience Knowledge of Amgen Medical review and case management SOPs and regulatory requirements for pharmacovigilance Clinical knowledge of therapeutic area patient populations and drug class Proficiency in technical safety systems including the Amgen Safety database and medical coding Knowledge of safety data capture in clinical trials and in the post marketing environments Knowledge of clinical trials and drug development Knowledge of Amgen products and patient population (preferred) Preferred Qualifications: MD/DO or international equivalent AND 4 years relevant work 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.

Medical Review Senior Associate Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will provide medical review of individual safety case reports (ICSR) in support of safety surveillance for Amgen products. Responsibilities: To support global individual case safety reports regulatory reporting compliance. To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT) Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. To act as a point of contact for Case Management on medical content of ICSRs Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports Execute ICSR case escalation as appropriate Execute appropriate case follow up per SOPs Support medical coding conventions, and systematic process improvements for ICSR medical review Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems. Support Quality Assurance of ICSR medical review (if applicable) Provide input on teams for interdepartmental and cross-functional initiatives including, process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review (if applicable) Perform other duties related to the position as necessary as defined in SOPs or as requested by their supervisor Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: MD/DO or international equivalent AND 1 year of related drug safety experience Knowledge of Amgen Medical review and Case Management SOPs and regulatory requirements for pharmacovigilance Clinical knowledge of therapeutic area patient populations and drug class Proficiency in technical safety systems including Safety Database and medical coding Knowledge of safety data capture in Clinical Trials and Post Marketing setting Knowledge of clinical trials and drug development Knowledge of Amgen products and patient population (preferred) Preferred Qualifications: MD/DO or international equivalent AND 3 years of relevant work 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.

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 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 Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, 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 submissions and related communications in the document management system Initiate and maintain CMC product 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: Master’s degree OR Bachelor’s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate’s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development 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