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Vice President Regulatory Affairs
Job in
San Francisco, San Francisco County, California, 94199, USA
Listed on 2026-10-16
Listing for:
Warman O'Brien
Full Time
position Listed on 2026-10-16
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
Warman O'Brien are proud to partner with an innovative clinical-stage biotech developing novel antibody therapeutics for autoimmune and immune-mediated diseases.
We are looking to appoint a VP, Regulatory Affairs to lead regulatory strategy and execution as the pipeline progresses.
The Role- Lead Regulatory Affairs across Clinical, CMC and regulatory strategy
- Own IND filings, amendments and preparation for FDA meetings
- Lead interactions with US and Australian regulatory authorities
- Support the lead program through Phase I and toward Phase II
- Work closely with Clinical, CMC and the senior leadership team
- Remain highly hands-on across submissions and regulatory execution
- Senior Regulatory Affairs leadership experience within biotech
- Strong experience with biologics and clinical-stage development
- Hands-on experience with IND submissions and FDA interactions
- Strong understanding of both Clinical and CMC regulatory requirements
- Experience with in autoimmune/immunology highly desirable
- Comfortable working hands-on within a lean, fast-moving biotech environment
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