Manager, Regulatory Affairs

About This Role

The Manager, Regulatory Affairs, works closely with the US Regulatory Lead and participates on cross-functional project teams and present the US regulatory position to senior management governance committees as needed.  This role is also open to Hybrid- RTP (Research Triangle Park location).

What You’ll Do

• Provide support and responsible for product labeling, FDA Requests for Information (safety-related), Type C Meeting requests, Post-Marketing Annual Reports, IND and Orphan Drug Annual Reports, USAN submissions, Proprietary name submissions, Structured Product Label submissions, Drug Listing, Monthly MedWatch submissions and Post Marketing requirements
• Provide cross-functional teams with US Labeling precedence when needed
• Interfaces with Regulatory Operations on submissions to the FDA
• Supports the submissions to the FDA to support INDs and/or marketing authorizations
• Acts as a core member of the US Labeling team and works collaboratively with the team to ensure implementation of the US Label.
• Provides regulatory due diligence assessments of new business opportunities if required

Who You Are

You have a deep understanding of regulatory requirements and the ability to adapt to evolving regulations in the pharmaceutical industry ensuring compliance with government regulations and industry standards within the pharmaceutical sector.

Required Education/Skills  

• Bachelor of Science degree in a scientific discipline
• Minimum of 5 years pharmaceutical industry experience in regulatory affairs
• Knowledge and understanding of applicable regulations
• Experience in interpretation of regulations, guidelines, policy statements

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.