Regulatory Affairs, Manager

Amgen Inc. South San Francisco , CA 94080

Posted 3 months ago

Career CategoryRegulatoryJob Description

Amgen is seeking a Regulatory Affairs, Manager to work in their Thousand Oaks, CA location. This position will report to Director Regulatory Affairs.

The Regulatory Affairs division establishes sustainable processes, assure informed relationships, and deliver strategic outcomes. Develop and implement regulatory strategies and processes for medical devices (eg, drug delivery devices, in-vitro diagnostics/companion diagnostics, software) and combination products.

Responsibilities of the Regulatory Affairs, Manager include:

  • Develop, implement, communicate, and maintain global regulatory strategies and plans

  • Support global filing activities and associated Health Agency meetings, including team reviews prior to submission

  • Review and approve device design control deliverables, as applicable per internal policies and procedures

  • Review standards and guidance for applicability; assist in establishing Amgen regulatory positions and communicating these to relevant stakeholders

  • Perform change management assessments; determine and communicate post-approval reporting requirements

  • Develop and support implementation and maintenance of regulatory processes

  • Support internal policy reviews for global regulatory guidance and regulations

  • Contribute to and participate in internal and external education and training activities

  • Identify and communicate relevant guidance, policies, standards, and regulations

  • Build and maintain effective relationships with internal and external stakeholders

  • Support supplier engagement teams and perform external due diligence regulatory activities

  • Advise on labeling requirements and perform regulatory review of labeling

  • Perform determination decisions for regulated items

  • Review regulatory sections in development, quality, and supply agreements

  • Support regulatory compliance initiatives

Basic Qualifications:

Doctorate

OR

Master's degree and 2 years of Regulatory experience

OR

Bachelor's degree and 4 years of Regulatory experience

OR

Associate's degree and 10 years of Regulatory experience

OR

High school diploma / GED and 12 years of Regulatory experience

Preferred Qualifications:

  • MS Degree

  • Degree in Regulatory Affairs, Life Sciences, or Engineering

  • 4+ years experience in Regulatory Affairs, including United States and international medical device and/or combination product regulations

  • 4+ years of experience in software development, IVD, or companion diagnostics

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.

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.


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Regulatory Affairs, Manager

Amgen Inc.