Executive Director Regulatory Affairs

Regulatory Strategy & Leadership

• 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.

Health Authority Engagement & Negotiations

• 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.

Labeling Strategy & Commercial Readiness

• 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.

Regulatory Submissions & Execution

• 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.

Cross-Functional & External Collaboration

• 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.

Team Development & Operational Excellence

• 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.

• 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.