Kyverna Therapeutics

Executive Director, Regulatory Affairs

Kyverna Therapeutics

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $270,000 - $300,000 per year

Job Level

Lead

About the role

  • Provide strategic and operational regulatory leadership across Kyverna's cell therapy portfolio, with a focus on commercial readiness, labeling strategy, and health authority engagement.
  • 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.

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.
Benefits
  • eligible for bonus
  • benefits
  • participation in the company's stock plan
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategylabeling strategyregulatory submissionsINDsCTAsBLAsMAAsregulatory compliancerisk managementclinical development
Soft Skills
strategic leadershipexecutive communicationteam leadershipinfluencing skillscollaborationmentoringaccountabilityproblem-solvingnegotiationadaptability