Executive Director, Regulatory Affairs

Role: 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, and collaborate cross-functionally with Clinical, CMC, Commercial, Market Access, and Legal teams. Lead and mentor regulatory teams, establish policies, and 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.