5151 Regulatory Jobs - Page 38

The AIN Sr Associate QA plays a critical role in supporting disposition related tasks across the Amgen Quality Operations Network. The Senior Associate QA will leverage industry, technical, and quality systems knowledge to provide support of business performance and GMP disposition supporting processes across the network. The position will be responsible for tasks including the key responsibilities documented below and other disposition related job functions. This candidate will primarily work during regular working hours (9 am 6 PM local time) to enable the business in delivering Amgens mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen ...

The Global HEOR Value Writing Senior Associate plays a critical role in supporting Amgens global market access strategy through high-quality Health Technology Assessment (HTA) deliverables. This role collaborates closely with team lead and Global HEOR Product Leads to ensure alignment with product strategy. The Value Writing Senior Associate develops Global Value Dossiers (GVDs), US AMCP dossiers, EU JCA dossiers, early HTA briefing books, reports and scientific publications ensuring content is scientifically rigorous, and will resonate with HTA and payer audiences. Key Responsibilities Develop and update Global Value Dossiers (GVDs), US AMCP dossiers, EU JCA dossiers, and early HTA briefing...

What you will do In this you will be the senior individual contributor within Amgens Enterprise Resource Planning (ERP) Testing team. this role requires a highly skilled testing professional who can take end-to-end ownership of SAP ERP testing activities and design/implement automation solutions from scratch using industry-leading tools Roles & Responsibilities: Testing Ownership Perform the planning, preparation, and execution of test cases for SAP ERP programs, ensuring alignment with project and compliance requirements. Perform hands-on testing (both manual and automated) while driving quality outcomes for ERP releases. Test Automation Leadership Design, build, and implement automation fr...

What you will do In this vital role you will serve as the operational head for a team of Global HEOR Value Writers (L5) supporting Amgens global market access and reimbursement. This role is accountable for ensuring the timely and high-quality development of payer- and HTA-relevant deliverables including Global Value Dossiers (GVDs), AMCP dossiers, early HTA briefing books, reports and scientific publications across multiple therapeutic areas. The Global HEOR Value Writing Leader aligns closely with the Global Head HTA Strategy & Project Management and the Global HEOR Product Leads on plans and timelines for the relevant deliverables. Lead, handle, and mentor a team of Global HEOR Value Writ...

Looking for a Business Analyst / QA role having min of 8+ years of experience. Resource should be well versed with Regulatory Reporting Job Description : Job Summary: We are seeking an experienced Oracle Financial Accounting Hub (FAH) Functional Testing Consultant to support the end-to-end implementation and testing of Oracle Fusion FAH modules. The ideal candidate will have deep expertise in Oracle Financials, strong testing methodologies, and a proven track record of working with global teams. Key Responsibilities: Lead and execute functional testing for Oracle FAH implementations, including SIT, UAT, regression , and integration testing . Collaborate with business analysts and finance tea...

Role Description: The International Regulatory Lead (IRL) Sr Associate will provide coordination and execution of regulatory deliverables for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: With support, advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Lia...

What you will do In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for quali...

Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Collaborate with team members to resolve problems and escalate issues Record and maintain written redaction strategy for the study and product Manage timelines and coordinate work across team Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compli...

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities

The Director leads the strategic development and execution of the Global Regulatory Intelligence (GRI) function, ensuring Amgen stays ahead of an evolving global regulatory landscape. This role defines the team's mission, sets priorities, leads cross-functional collaborations, and ensures high-impact intelligence is embedded into regulatory strategy across the enterprise. Key Responsibilities: Function Leadership & Vision: Establish and evolve the Regulatory Intelligence function, defining structure, staffing strategy, vendor/outsourcing model, and the technology roadmap to support global operations. Set the vision and oversee the execution of intelligence deliverables that enable accelerate...

Job Summary : Experienced Privacy Professional to work in the Worldwide Compliance & Business Ethics (WC&BE) Department of a global Pharmaceutical/biotechnology headquartered in Southern California The individual will be located in Hyderabad and support Amgens Privacy Compliance program in Asia and be part of the international privacy compliance team The individual will report directly to the Chief Privacy Officer Roles and Responsibilities : Provide advice, guidance and/or support to local Compliance professionals regarding: Any data protection issues arising at respective affiliates Data Protection Authority (DPA) Notifications and Prior Approval submissions Data Subject Inquiry responses ...

Roles and Responsibilities: Conduct quality assurance reviews and process the daily release of FDA Form 2253 reportable submissions for promotional materials referencing marketed products. Evaluate creative file submissions and system metadata of marketing materials, ensuring completeness, accuracy, and compliance with licensing requirements. Collaborate with creative agencies and marketing teams to oversee the renegotiation, renewal and collection of usage rights for marketing materials. Leverage company subscriptions to provide art procurement services in support of Amgens marketing initiatives. Retrieve, validate, and distribute digital asset packages to agencies and marketing teams, util...

The Manager in the Global Regulatory Intelligence team is a hands-on contributor responsible for gathering and organizing regulatory intelligence under the guidance of the RI Director. This role often has a technology and data focus , managing the tools and information that drive the intelligence process. Key Responsibilities: Intelligence Gathering & Analysis: Assist in monitoring and analyzing the global regulatory landscape, and in developing intelligence reports and updates as directed by the RI Director. A core duty is to collect and synthesize new or updated local regulatory requirements obtained from Amgens local regulatory teams, for the Managers assigned areas of responsibility. Thi...

RESPONSIBILITIES GCP Subject Matter Expert - Provide independent and objective quality advice in support of clinical trial activities and in line with current best practice. Provide quality oversight for Amgen programmes for all stages of products in clinical development Ensure quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to guarantee the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights Support the establishment of regional expertise to ensure quality and compliance to local Regulations Support Clinical Trial Teams for all quality management activities, including Deviati...

Position Summary The Global HEOR Value Writing Manager plays a critical role in supporting Amgens global market access strategy through high-quality Health Technology Assessment (HTA) deliverables. This role collaborates closely with Global HEOR Product Leads to ensure alignment with product strategy. The Value Writing Manager develops Global Value Dossiers (GVDs), US AMCP dossiers, EU JCA dossiers, early HTA briefing books, reports and scientific publications ensuring content is scientifically rigorous, and will resonate with HTA and payer audiences. Key Responsibilities Develop and update Global Value Dossiers (GVDs), US AMCP dossiers, EU JCA dossiers, and early HTA briefing books across m...

Role description: Amgen is seeking a Regulatory Affairs Associate Director supporting lifecycle management for approved, mature products across all Amgen Therapeutic Areas. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this important, product-facing role you will lead assigned Global Regulatory Teams (GRT) in the Regulatory Affairs organization. The role of the Regulatory Affairs Associate Director is to lead GRTs within Amgens GRAAS organization, develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements, maintai...

Role Name: Manager International Regulatory Lead (IRL) Department Name: International Regulatory Team, Global Regulatory Affairs Role GCF: 5A ABOUT THE ROLE Role Description The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to -optimize product development and regulatory approvals in International countries -develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities -Advises Global teams on regulatory impl...

Position Summary: The AIN Specialist QA plays a critical role in supporting product disposition related tasks across the Amgen Quality Operations Network. The Specialist QA will leverage industry, technical, and quality systems knowledge to provide support of product expiry management processes, product complaints processes, disposition manager training, and fulfillment of disposition related data requests across the network. The position will be responsible for tasks including the key responsibilities documented below and other disposition related job functions. This candidate will primarily work during regular working hours (9 am 6 PM local time) to enable the business in delivering Amgens...

Role Name: Sr Associate Quality Compliance Documentation Lead Department Name: R&D Quality Role GCF: 4 Role Description: The Controlled Documentation Lead supports end-to-end lifecycle management of R&D controlled documents to ensure compliance with regulatory standards and internal quality procedures. This role emphasizes quality control, template adherence, and milestone tracking. The lead works closely with stakeholders to coordinate document workflows, perform rigorous QC reviews, and ensure timely and accurate completion of documentation deliverables within the electronic document management system. Roles & Responsibilities: Coordinate and manage document workflows (e.g., SOPs, template...

Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Collaborate with team members to resolve problems and escalate issues Record and maintain written redaction strategy for the study and product Manage timelines and coordinate work across team Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compli...

What you will do In this vital role you will provide technical expertise and product leadership to the Product Quality (PQ) organization. As a product support staff in Quality, the Product Quality Specialist has responsibility for working with Product Quality Leaders (PQL), International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other groups on projects including support of product specifications, in-process controls, periodic and annual product review, and complaint resolutions. Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of t...

This role will support one or more late-stage and/or commercial biologics or synthetics products. The individual will provide project support to the relevant Product Quality Team (PQT) to implement and manage strategy for Quality to meet the Product Quality goals. The individual will be directly responsible for Product Quality related tasks including authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (document management system, complaint resolution system, data systems), and product data management, including stability, comparability assessments, periodic and annual product reviews (APR). In addition, the candidate will be expected to pla...

ABOUT THE ROLE Role Description: We are seeking a Senior Data Engineering Manager with a strong background in Regulatory or Integrated Product Teams within the Biotech or Pharmaceutical domain. This role will lead the end-to-end data strategy and execution for regulatory product submissions, lifecycle management, and compliance reporting, ensuring timely and accurate delivery of regulatory data assets across global markets. You will be embedded in a cross-functional Regulatory Integrated Product Team (IPT) and serve as the data and technology lead, driving integration between scientific, regulatory, and engineering functions to support submission-ready data and regulatory intelligence soluti...

Job Summary: Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance. Join us in revolutionizing regulatory submissions through cutting-edge data automation! Key Responsibilities: Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows. Assist in developing standardized templates a...

What you will do In this vital role you will Prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standards Write or oversee the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phase 1 through 4) Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety documents, across therapeutic areas and for biosimilars (mandate) Write other regulatory submission documents (eg, RTQs, PIP, white papers, breakthrough therapy...