Associate Director, GRS Heme/Onc
Bristol Myers Squibb · Princeton, NJ
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Role summary
This role leads regulatory strategy and submissions for hematology/oncology products across development and lifecycle stages. The Associate Director manages global regulatory dossier submissions to FDA and other authorities, coordinates cross-functional teams, and represents regulatory functions on project teams. The position requires a scientific degree, 4–8 years of pharmaceutical experience with 3–5 years in regulatory affairs, and demonstrated expertise in IND/NDA processes.
What they're looking for
- PhD, MD, PharmD, or BS/MS in regulatory science
- 4-8 years pharmaceutical industry experience with 3-5 years in regulatory affairs
- Thorough knowledge of IND and NDA drug development processes
- Demonstrated experience preparing FDA submissions for INDs and NDAs
- Strong team leadership experience with cross-functional influence
- Ability to work independently with minimal supervision and attention to detail
- Experience coordinating global regulatory activities across organizational boundaries
What you'll be doing
- Develop global regulatory strategy in conjunction with team leadership for development and lifecycle management
- Lead regulatory dossier submissions to FDA and global authorities utilizing internal and external resources
- Write and review regulatory documents including INDs, briefing books, and priority review requests
- Participate in and lead regulatory interactions with FDA as assigned
- Collaborate on cross-functional rapid response teams addressing clinical trial application queries
Privacy & handoff
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