Amgen Regulatory Affairs Mgr - CMC Global in Cambridge, Massachusetts

Amgen is seeking a Regulatory Manager (CMC). The Regulatory Manager will work out of the site in Cambridge MA or our main corporate campus in Thousand Oaks, CA.

The Regulatory 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.

Key responsibilities of the Regulatory Manager include:

  • Define minimum regulatory filing requirements for post approval programs

  • Provide regulatory strategy through development of variation strategic plans and/or eventglobal regulatory strategy

  • Develope 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

  • Liaise with other Functions in development, operations, and commercial to ensure alignment of globalregulatory strategies, timing, execution and plans

  • Contribute to the Product Delivery Teams Variation Master Plan

  • Monitor and 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 including GRT, PDT, PQT, etc.

Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Regulatory CMC & Compliance and/or Quality experience

OR

Bachelor's degree and 5 years of Regulatory CMC & Compliance and/or Quality experience

OR

Associate's degree and 10 years of Regulatory CMC & Compliance and/or Quality experience

OR

High school diploma / GED and 12 years of Regulatory CMC & Compliance and/or Quality experience

Preferred Qualifications

BS Degree in life sciences, biochemistry or chemistry

Experience in leading regulatory CMC submissions

Experience with manufacture, quality, or regulatory of small molecule therapeutics

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.

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.