Regulatory Affairs Manager, CMC

Thousand Oaks, CA, US
Sep 20, 2019
Required Education
Bachelors Degree
Position Type
Full time
Amgen is searching for a Regulatory Affairs Manager, CMC (Chemistry, Manufacturing and Controls). It is anticipated this person will work from the main corporate campus in Thousand Oaks, CA, however qualified candidates from the AMA and APR sites will also be considered.

The Regulatory Affairs Manager, CMC will provide regulatory strategy for lifecycle management (Commercial) products, including determining regulatory reporting, and global filing requirements for post approval variations. The Manager will also facilitate communication of requirements and strategy to Process Development Team (PDT) in addition to the functional areas. The Manager will follow standard department and global marketing template processes to drive consistency across post approval programs.

Serve as Regulatory CMC voice for product teams by providing the following services:

  • Define minimum regulatory filing requirements for post approval programs
  • Provide regulatory strategy through development of marketing application strategic plan and/or events
  • Global regulatory strategy
  • Development of post approval variations including maintenance of applications
  • Maintain product compliance through appropriate regulatory filings and activities
  • Support Change Management activities
  • Respond to regulatory agency questions
  • Facilitate agency interactions, including meeting preparation, meetings and briefing documents
  • Ensure alignment with variation master plans, develop global implementation requirements, and implement changes throughout product life-cycles
  • Liaise with other Functions in development, operations, and commercial to ensure alignment of global regulatory strategies, timing, execution and plans
  • Contribute to the Product Delivery Teams Variation Master Plan
  • Maintain information for Center dashboards; and collaborate with other Centers to ensure information alignment
  • Monitor and, as necessary, provide data to be entered into tracking systems (e.g., IMR) for department deliverables and ensure information is current
  • Participate as an active member of cross-functional teams including GRT, PDT, PQT, etc., as needed

Basic Qualifications
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

Preferred Qualifications
  • Degree in Life Science
  • Experience in manufacture, testing (QC/QA or clinical), process development or other related Pharmaceutical/Biotech industry
  • Regulatory CMC experience with small molecule and Biologic products
  • CMC-specific regulatory knowledge & experience

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.