We have an exciting opportunity for a high-impact Director of Regulatory Affairs to lead global strategy for a priority immunology program at a pivotal late-stage moment. This role owns regulatory direction toward registration, serving as the key voice in FDA interactions and driving INDs, lifecycle strategy, and global submissions.
With real autonomy and visibility, you'll shape cross-functional decisions, influence clinical and CMC strategy, and help build regulatory infrastructure in a fast-growing biotech environment. If you bring deep small-molecule expertise and thrive where strategy meets execution, this is a chance to make a meaningful impact on a program with real momentum.
Key highlights:
• Own global regulatory strategy for a late-stage immunology program
• Lead FDA engagement and high-stakes regulatory interactions
• Drive submissions, lifecycle planning, and global filings
• Partner cross-functionally across clinical, CMC, and leadership teams
• High-visibility role with strong influence and autonomy
• Opportunity to help shape regulatory infrastructure in a growing biotech
