Executive Director, Regulatory Affairs

Job Description

Kyverna Therapeutics is seeking an Executive Director of Regulatory Affairs to provide strategic and operational leadership across its cell therapy portfolio. This role focuses on ensuring commercial readiness, crafting labeling strategies, and managing health authority engagement. The Executive Director will lead global regulatory strategies for Kyverna's development programs, aligning clinical, CMC, and commercial objectives from early development through post-approval lifecycle management. This leadership role includes providing regulatory input to program governance, asset prioritization, and portfolio decisions, including scenario planning and risk mitigation. Anticipating and addressing regulatory challenges related to cell therapy development, manufacturing, comparability, and long-term follow-up is crucial. The Executive Director will serve as the primary senior regulatory interface with global health authorities, including FDA and EMA. Key responsibilities include leading regulatory meetings, driving negotiation strategies, owning labeling strategy, developing Target Product Profiles (TPPs), and partnering with Commercial, Medical Affairs, and Market Access teams. The Executive Director will also oversee the preparation and submission of regulatory filings, act as a strategic partner to various internal teams, provide regulatory due diligence, oversee regulatory activities, and mentor a high-performing regulatory team. This role requires establishing and maintaining regulatory policies and procedures to support a growing organization.

Qualifications

1. Bachelor's degree in a scientific discipline required; an advanced degree is preferred. 2. Requires 15+ years of progressive regulatory affairs experience in pharmaceutical or biotechnology, with significant advanced therapy experience. 3. Experience in cell and/or gene therapy is preferred; experience with autoimmune diseases is highly preferred. 4. Must have demonstrated success leading global regulatory strategies through late-stage development and/or approvals, ideally including BLA/MAA experience. 5. Proven experience with labeling strategy development and negotiation, with a strong understanding of commercialization impacts. 6. Deep knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks is required; EMA and ex-US experience is preferred. 7. A track record of effective engagement with FDA OTP and/or divisions overseeing autoimmune or immune-mediated diseases is necessary. 8. Requires strong executive communication skills with the ability to influence senior leadership and Board-facing audiences. 9. Demonstrated ability to lead and scale teams in a fast-paced, high-growth environment. Prior supervisory experience is preferred. 10. Must have a strategic mindset with the ability to balance scientific rigor, regulatory compliance, and commercial impact.

Benefits

- Eligible for bonus. - Comprehensive benefits package. - Participation in the company's stock plan.