Executive Director, Regulatory Affairs

📋 Description

• • The Executive Director, Regulatory Affairs provides strategic and operational regulatory leadership across Kyverna's cell therapy portfolio, focusing on commercial readiness, labeling strategy, and health authority engagement to support the development and commercialization of autoimmune cell therapies.
• • Day-to-day responsibilities include defining and executing global regulatory strategy for clinical development, registration, and commercialization; translating scientific and clinical data into approvable, commercially viable labeling; and leading interactions with regulatory authorities such as the FDA and global counterparts.
• • Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases, guided by core values of staying true to mission, collaboration, clarity, innovation, and accountability, committed to transforming treatment futures.
• • The role offers the opportunity to shape regulatory strategy from early development through approval and launch, partner closely with Clinical, CMC, Commercial, Market Access, and Legal teams, and make a direct impact on bringing innovative autoimmune therapies to patients.