Executive Director, Regulatory Affairs
Scorpion Therapeutics
Senior strategic leader overseeing global regulatory affairs for Kyverna's cell therapy portfolio, focusing on autoimmune indications from early development through commercialization. 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. Requirements 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. Preferred Advanced degree. Autoimmune therapy experience. Global regulatory expertise. Work setup Remote (West Coast hours preferred). Senior level with high-impact regulatory leadership. #J-18808-Ljbffr Scorpion Therapeutics
Vacancy posted 4 days ago
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