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Executive Director, Regulatory Affairs
Job in
San Francisco, San Francisco County, California, 94199, USA
Listed on 2026-10-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-09
Job specializations:
-
Management
Regulatory Compliance Specialist -
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
Responsibilities
- Define and execute regulatory strategies.
- Lead interactions with FDA and global authorities.
- Develop labeling.
- Manage submissions (INDs, BLAs, MAAs).
- Oversee regulatory negotiations.
- Collaborate cross-functionally with Clinical, CMC, Commercial, Market Access, and Legal teams.
- Lead and mentor regulatory teams.
- Establish policies.
- Manage CRO/vendor activities.
- 15+ years in pharma/biotech regulatory affairs with significant experience in advanced therapies, ideally cell/gene therapy with autoimmune disease focus.
- Deep knowledge of FDA, ICH, EMA regulations; success in late-stage development and approvals (BLA/MAA).
- Strong leadership, strategic thinking, and executive communication skills.
- Advanced degree.
- Autoimmune therapy experience.
- Global regulatory expertise.
- Remote (West Coast hours preferred).
- Senior level with high-impact regulatory leadership.
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