Amgen
biotechnology
RegulatoryAffairsManager
Neural analysis suggests this role is
optimal for Senior candidates.
“Regulatory Affairs Manager at Amgen. Skills: Regulatory Affairs, CMC, Regulatory CMC strategy, CMC regulatory filings, CMC regulatory strategy for assigned projects, CMC regulatory strategy and submission documents. input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for the specific site. coordinates preparation of regulatory filings”
What You'll Achieve.
ensures the company’s compliance with all regulations and laws pertaining to the company’s business; meeting the demands of an industry-leading, fast paced organization; delivering sound RA CMC strategies and submission documents for maintaining the compliance of current Marketing Applications related to Amgen’s synthetics molecule portfolio
Industry & Context.
identifies issues and factors that may impact a regulatory strategy or activity; Respond to regulatory agency questions
What They're Looking For.
Must Have
Doctorate Degree, Master's Degree and 3 years of Regulatory CMC or related technical experience, Bachelor's Degree and 5 years of Regulatory CMC or related technical experience, Associates degree and 10 years of Regulatory CMC or related technical experience
Nice to Have
Degree in Life Science, Regulatory CMC knowledge and experience with small molecule and/or Biologic products, Experience in manufacture, testing (QC/QA or clinical), process development or other related Pharmaceuticaliotech industry
What You'll Do.
input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for the specific site
coordinates preparation of regulatory filings
identifies issues and factors that may impact a regulatory strategy or activity
confirmation on change control regulatory assessments
key RA CMC representative on product deviation investigation teams
Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements
and regulatory risk assessments
Support development of global dossiers for CMC content of new marking applications (MAA)
new clinical trials (CTA)
variations and amendments to existing MAA/ CTAs
Development of post-approval submissions including maintenance of applications
Support Change Management activities
Respond to regulatory agency questions
Liaise with the Global RA CMC product lead
ROOTS representatives
and other functions in development
and commercial to ensure alignment of global regulatory strategies and timing
provide data to be entered into tracking systems for department deliverables and ensure information is current
Participate as an active member of cross-functional teams
How You'll Work.
Team & Collaboration
interfaces with the site (R&D and operations authors); members of CMC product teams; Liaise with the Global RA CMC product lead, ROOTS representatives, and other functions in development, operations, and commercial to ensure alignment of global regulatory strategies and timing, execution; Participate as an active member of cross-functional teams; global team with remote team members across the US, Ireland, Breda and Puerto Rico; RA CMC team is part of the Global Regulatory Affairs and Strategy (GRAAS) organization under the Amgen Research and Development Division; We all work together to serve every patient every time by meeting the demands of an industry-leading, fast paced organization
Communication Scope
Respond to regulatory agency questions; Liaise with the Global RA CMC product lead, ROOTS representatives, and other functions in development, operations, and commercial to ensure alignment of global regulatory strategies and timing, execution
Full Job Description
## **Career Category** Regulatory ## ## **Job Description** The Regulatory Affairs Manager at Amgen ensures the company’s compliance with all regulations and laws pertaining to the company’s business. They work with federal, state, and local regulatory agencies on issues and regulations that affect the company’s products and services. If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. **REGULATORY AFFAIRS MANAGER, CMC (CHEMISTRY, MANUFACTURING AND CONTROLS)** **LIVE** **What you will do** The RA CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for the specific site. The CMC site team interfaces with the site (R&D and operations authors), coordinates preparation of regulatory filings, identifies issues and factors that may impact a regulatory strategy or activity. The CMC site team are members of CMC product teams. The CMC Site team is also responsible for confirmation on change control regulatory assessments with input from the CMC Product teams and the CMC Region representative. The CMC site team is the key RA CMC representative on product deviation investigation teams. * Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments * Support development of global dossiers for CMC content of new marking applications (MAA), new clinical trials (CTA), variations and amendments to existing MAA/ CTAs. * Development of post-approval submissions including maintenance of applications * Support C
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