Partner Companies

Amgen

Amgen Website
One Amgen Center Drive, Thousand Oaks, CA 91320

Fellowship Duration

2 Years

Fellowship Positions Available

Global Regulatory Affairs

Global Regulatory Affairs and Safety (Rotational)

Company Information

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.

Fellowship Description

In partnership with the Rutgers Institute for Pharmaceutical Industry Fellowships, Amgen is offering two post-doctoral fellowships, each two years in duration.  The Amgen pipeline and portfolio consist predominantly of complex biotechnology products, which afford the fellows the opportunity to work on scientifically rewarding products with the aim to focus on areas of high unmet medical need and dramatically improve people’s lives.

Global Regulatory Affairs (GRA) Fellowship

The Global Regulatory Affairs (GRA) fellow will follow a structured and supported development plan, preparing for a rewarding career in regulatory affairs. Leveraging the scientific knowledge of a pharmacist alongside learned business acumen and negotiation skills, this role offers a breakthrough entry into the ever-changing field of regulatory affairs. With a focus on U.S. regulatory affairs, this fellow will have the opportunity to prepare for and facilitate interactions with the Food and Drug Administration (FDA), craft and communicate regulatory strategies across many functions within Amgen, and learn to plan and execute regulatory submissions.   The role will liaise with regulatory staff globally, acquire a better understanding of the drug development process and the role of regulatory affairs, and learn to navigate the complex matrix and team environment at a large pharmaceutical company.

Global Regulatory Affairs and Safety (GRAAS) Fellowship

The Global Regulatory Affairs and Safety (GRAAS) fellow will follow a rotational development plan within a variety of teams, such as Global Regulatory Affairs, Regional Regulatory Affairs, Global Patient Safety and Labeling, Global Regulatory and R&D Policy, and Regulatory Chemistry Manufacturing and Controls (CMC). The fellow will gain hands-on experience in multiple functions within an accelerated time period, providing a unique opportunity to clarify their interests in the diverse field of regulatory affairs and safety.  Competency areas the fellow may develop expertise for include: safety surveillance, risk management, benefit-risk assessment, regulatory strategy, review and approval of labeling and promotional materials, and regulatory policy.  In each rotation, the fellow will have the opportunity to work with staff globally and learn to navigate the complex matrix and team environment at a large pharmaceutical company.  This rotational structure will prepare the fellow for a career in a function to be determined in the second half of the fellowship, tailored to personal interests, strengths and targeted areas for development.  

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