Executive Director Regulatory Affairs

About the Role

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. The Executive Director, Regulatory Affairs will provide strategic and operational regulatory leadership, focusing on commercial readiness, labeling strategy, and health authority engagement.

Responsibilities

• Regulatory Strategy & Leadership: Lead global regulatory strategy for development programs, aligning clinical, CMC, and commercial objectives from early development through post-approval.
• Health Authority Engagement & Negotiations: Serve as the primary senior regulatory interface with FDA, EMA, and other global health authorities; lead key meetings including INTERACT, pre-IND, and pre-BLA/MAA.
• Labeling Strategy & Commercial Readiness: Own labeling strategy to ensure commercial differentiation and lead development of Target Product Profiles (TPPs).
• Regulatory Submissions & Execution: Oversee the preparation and submission of INDs, CTAs, BLAs/MAAs, and briefing packages.
• Cross-Functional Collaboration: Act as a strategic partner to Clinical, CMC, Research, and Commercial teams while providing regulatory due diligence for business development.
• Team Development: Lead and scale a high-performing regulatory team, fostering accountability and operational excellence.

Qualifications

• Bachelor's degree in a scientific discipline required; advanced degree preferred.
• 15+ years of progressive regulatory affairs experience in pharmaceutical or biotechnology.
• Significant advanced therapy experience (cell and/or gene therapy); autoimmune disease experience highly preferred.
• Demonstrated success leading global regulatory strategies through late-stage development and approvals.
• Deep knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks (EMA and ex-US).
• Strong executive communication skills and ability to lead in a fast-paced environment.

Required Skills