Remote Executive Director, Global Regulatory Affairs

Kyverna Therapeutics; United States; Remote; USD 270,000 - 300,000; Full time

Benefits offered by this job

Bonus

Stock plan

Benefits

Job summary

Kyverna Therapeutics seeks an Executive Director, Regulatory Affairs to lead global regulatory strategy from development through launch, interfacing with FDA, EMA, and other authorities. The role shapes labeling, risk mitigation, and lifecycle management while partnering with Clinical, CMC, Commercial, Market Access, and Legal teams.

The ideal candidate brings 15+ years in regulatory affairs, advanced therapy experience, and a proven track record of leading teams in a fast-paced environment.

Qualifications

• 15+ years of progressive regulatory affairs experience in pharmaceutical/biotechnology with advanced therapy experience.
• Cell and/or gene therapy experience preferred; autoimmune disease experience highly preferred.
• Proven experience leading global regulatory strategies through late-stage development and approvals (BLA/MAA).
• Experience with labeling strategy development and negotiation and understanding of commercialization impacts.
• Deep knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks; EMA and ex-US experience preferred.
• Strong executive communication skills with the ability to influence senior leadership and Board audiences.
• Demonstrated ability to lead and scale teams in a fast-paced, high-growth environment; supervisory experience preferred.
• Strategic mindset balancing scientific rigor, regulatory compliance, and commercial impact.

Responsibilities

• Lead global regulatory strategy for Kyverna's development programs from early development through post-approval lifecycle management.
• Provide regulatory input to governance and portfolio decisions, including risk mitigation.
• Serve as primary senior regulatory interface with FDA, EMA, and other authorities.
• Lead and/or support key regulatory meetings (INTERACT, pre-IND, End-of-Phase, pre-BLA/MAA, etc.).
• Drive regulatory negotiation strategy including endpoints, comparability, and post-approval requirements.
• Own and drive labeling strategy from development through approval for commercial differentiation.
• Lead development of Target Product Profiles and alignment across Clinical, Regulatory, Commercial, and Market Access.
• Partner with Commercial, Medical Affairs, and Market Access to support launch readiness.

Skills

Regulatory strategy

Global leadership

FDA/EMA engagement

Regulatory submissions

Team leadership

Cross-functional collaboration

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

Kyverna Therapeutics seeks an Executive Director, Regulatory Affairs to lead global regulatory strategy from development through launch, interfacing with FDA, EMA, and other authorities. The role shapes labeling, risk mitigation, and lifecycle management while partnering with Clinical, CMC, Commercial, Market Access, and Legal teams.

The ideal candidate brings 15+ years in regulatory affairs, advanced therapy experience, and a proven track record of leading teams in a fast-paced environment.