Executive Director, Regulatory Affairs

Job description

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 ### Responsibilities - Lead global regulatory strategy for Kyverna's development programs, aligning clinical, CMC, and commercial objectives from early development through post-approval lifecycle management. - Provide regulatory input to program governance, asset prioritization, and portfolio decisions, including scenario planning and risk mitigation. - Anticipate and address regulatory challenges related to cell therapy development, manufacturing, comparability, and long-term follow-up. - Serve as the primary senior regulatory interface with FDA, EMA, and other global health authorities. - Lead and/or support key regulatory meetings, including INTERACT, pre-IND, End-of-Phase, pre-BLA/MAA, Advisory Committees, and post-marketing commitments. - Drive regulatory negotiation strategy, including benefit-risk, endpoints, comparability, and post-approval requirements. - Own and drive labeling strategy from early development through approval, ensuring labels support commercial differentiation, patient access, and lifecycle value. - Lead development of Target Product Profiles (TPPs) and ensure alignment across Clinical, Regulatory, Commercial, and Market Access. - Partner with Commercial, Medical Affairs, and Market Access to ensure regulatory decisions support launch readiness, promotional strategy, and payer engagement. - Lead label negotiations with health authorities, balancing scientific evidence, regulatory expectations, and commercial objectives. - Oversee and contribute to the preparation, review, and submission of INDs, CTAs, BLAs/MAAs, briefing packages, orphan drug applications, and other regulatory filings. - Ensure submissions are high-quality, compliant, and strategically positioned. - Maintain oversight of submission timelines, dependencies, and risk management, providing clear communication to senior leadership. - Act as a strategic partner to Clinical Development, CMC, Research, Commercial, Legal, BD, and Alliance Management teams. - Provide regulatory due diligence and strategic input for business development, in-licensing, out-licensing, and partnership opportunities. - Oversee regulatory activities performed by CROs, consultants, and partners, ensuring quality and strategic alignment. - Lead, mentor, and scale a high-performing regulatory team, fostering accountability, development, and a culture of collaboration. - Establish and maintain regulatory policies, procedures, and infrastructure to support a growing, late-stage organization. - Stay current on US and global regulatory intelligence and communicate key implications to stakeholders. ### Requirements - Bachelor's degree in a scientific discipline required; advanced degree preferred. - 15+ years of progressive regulatory affairs experience in pharmaceutical or biotechnology, with significant advanced therapy experience. - Cell and/or gene therapy experience preferred; autoimmune disease experience highly preferred. - Demonstrated success leading global regulatory strategies through late-stage development and/or approvals, ideally including BLA/MAA experience. - Proven experience with labeling strategy development and negotiation, with strong understanding of commercialization impacts. - Deep knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks; EMA and ex-US experience preferred. - Track record of effective engagement with FDA OTP and/or divisions overseeing autoimmune or immune-mediated diseases. - Strong executive communication skills with the ability to influence senior leadership and Board-facing audiences. - Demonstrated ability to lead and scale teams in a fast-paced, high-growth environment. Prior supervisory experience preferred. - Strategic mindset with the ability to balance scientific rigor, regulatory compliance, and commercial impact.