Regulatory Affairs Sr Manager
Amgen
August 21, 2026
Remote friendly (Illinois, United States)
United States
Corporate Functions
Regulatory Affairs Sr Mgr
Responsibilities:
- Formulate and present CMC regulatory strategies aligned with corporate objectives across investigational and marketed products.
- Develop risk registers for major regulatory submissions, including mitigation proposals.
- Coordinate preparation of CMC components of regulatory submissions.
- Guide and contribute to CMC-related documents for regulatory submissions, Health Authority meeting requests, and briefing books to meet regulatory standards and be approvable on first review cycle.
- Develop strategies and prepare responses to CMC-related topics with health authorities.
- Review manufacturing/testing change controls and provide regulatory impact assessments.
- Represent and support CMC regulatory on multidisciplinary project teams; provide CMC regulatory guidance.
- Ensure compliance with Health Authority expectations and regulatory guidance.
- Maintain and communicate knowledge of current/emerging CMC regulatory environments, guidelines, and best practices.
Requirements:
- Master’s degree (or foreign equivalent) in Regulatory Science, Environmental, Safety and Health management or related field + 6 years’ experience in the job offered or in an Associate or regulatory-related occupation.
- 6 years’ experience in:
- Leading interactions with Regulatory Agencies (briefing documents, meeting logistics).
- Organizing/preparing/reviewing CMC content for clinical trial or marketing applications.
- Compiling CMC quality data using Veeva Vault.
- Developing/ managing project timelines and deliverables.
- Knowledge of international drug-development standards (GLP, GCP, GMP).
- Knowledge of FDA organization, roles, and responsibilities for drug development.
- Analyzing, summarizing, and interpreting scientific data considering limitations.
Application:
- Apply at https://careers.amgen.com/en/search-jobs and search job # R-248046.
Benefits:
- Stock; retirement; medical, life and disability insurance; eligibility for annual bonus or other incentive compensation (per job posting).
Responsibilities:
- Formulate and present CMC regulatory strategies aligned with corporate objectives across investigational and marketed products.
- Develop risk registers for major regulatory submissions, including mitigation proposals.
- Coordinate preparation of CMC components of regulatory submissions.
- Guide and contribute to CMC-related documents for regulatory submissions, Health Authority meeting requests, and briefing books to meet regulatory standards and be approvable on first review cycle.
- Develop strategies and prepare responses to CMC-related topics with health authorities.
- Review manufacturing/testing change controls and provide regulatory impact assessments.
- Represent and support CMC regulatory on multidisciplinary project teams; provide CMC regulatory guidance.
- Ensure compliance with Health Authority expectations and regulatory guidance.
- Maintain and communicate knowledge of current/emerging CMC regulatory environments, guidelines, and best practices.
Requirements:
- Master’s degree (or foreign equivalent) in Regulatory Science, Environmental, Safety and Health management or related field + 6 years’ experience in the job offered or in an Associate or regulatory-related occupation.
- 6 years’ experience in:
- Leading interactions with Regulatory Agencies (briefing documents, meeting logistics).
- Organizing/preparing/reviewing CMC content for clinical trial or marketing applications.
- Compiling CMC quality data using Veeva Vault.
- Developing/ managing project timelines and deliverables.
- Knowledge of international drug-development standards (GLP, GCP, GMP).
- Knowledge of FDA organization, roles, and responsibilities for drug development.
- Analyzing, summarizing, and interpreting scientific data considering limitations.
Application:
- Apply at https://careers.amgen.com/en/search-jobs and search job # R-248046.
Benefits:
- Stock; retirement; medical, life and disability insurance; eligibility for annual bonus or other incentive compensation (per job posting).