Director Regulatory Affairs
On-site · Boston, Massachusetts, United States
Job Summary
Director Regulatory Affairs responsible for owning global regulatory strategy for a late-stage immunology program, leading FDA engagement and high-stakes regulatory interactions, and driving submissions, lifecycle planning, and global filings. Partners cross-functionally with clinical, CMC, and leadership teams to shape regulatory infrastructure in a fast-growing biotech, with high-visibility and autonomy. The role emphasizes deep small-molecule regulatory expertise and translating strategy into execution across global regulatory activities.
Required Qualifications
- Experience leading regulatory strategy for late-stage biotech programs
- FDA engagement experience
- Regulatory submissions lifecycle planning
- Cross-functional leadership across clinical, CMC, and leadership teams
- Small-molecule regulatory expertise
- Ability to build regulatory infrastructure in biotech
- Strategic influence with autonomy
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