Amgen Regulatory Affairs Director - Global Regulatory Leader in Thousand Oaks, California
The Global Regulatory Leader (GRL), as the regulatory affairs representative on one or more cross-functional product teams, leads Global Regulatory Team(s) to develop and execute a comprehensive regulatory strategy to drive global product development and registration, achieving and maintaining desired regional labeling.
Global Regulatory Affairs provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules.
The GRL is responsible for:
Development and execution of the global regulatory product strategy
Leading global regulatory team(s)
Representing Global Regulatory Affairs on the product teams and key internal governance bodies
Directing global regulatory agency interaction strategies, in collaboration with regional colleagues
Attending key regulatory agency meetings which could impact the global product strategy
Participating in external review process for commenting based on expertise
Developing regulatory due diligence assessment of licensing/acquisition opportunities
Doctorate degree and 4 years of regulatory or drug development experience
Master's degree and 8 years of regulatory or drug development experience
Bachelor's degree and 10 years of regulatory or drug development experience
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.