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.
Master's degree and 3 years of Regulatory CMC & Compliance and/or Quality experience
Bachelor's degree and 5 years of Regulatory CMC & Compliance and/or Quality experience
Associate's degree and 10 years of Regulatory CMC & Compliance and/or Quality experience
High school diploma / GED and 12 years of Regulatory CMC & Compliance and/or Quality experience
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.