Executive Director, Regulatory Affairs

 

The Executive Director, Regulatory Affairs will provide strategic and operational regulatory leadership across Kyverna's cell therapy portfolio, with a focus on commercial readiness, labeling strategy, and health authority engagement.

The ideal candidate is a seasoned regulatory leader with deep experience in advanced therapies who can shape regulatory strategy from early development through approval and launch, while partnering closely with Clinical, CMC, Commercial, Market Access, and Legal teams.

The Executive Director will define and execute global regulatory strategy to support clinical development, registration, and commercialization of Kyverna's autoimmune cell therapies. The role requires the ability to translate scientific and clinical data into approvable, commercially viable labeling and to lead interactions with regulatory authorities, including FDA and global counterparts.

Title: Executive Director, Regulatory Affairs

Location: Remote (West Coast hours preferred)

Reports to: SVP, Chief Regulatory Officer