Remote Executive Director Regulatory Affairs

\n\nKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.\n \nTitle: Executive Director, Regulatory Affairs\nLocation: Remote (West Coast hours preferred)\nReports to: SVP, Chief Regulatory Officer\n \nPosition Overview\nThe 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.\nThe 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.\nThe 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.\n\n\n\n\n\nResponsibilities\nRegulatory Strategy & Leadership\n\nLead global regulatory strategy for Kyverna's development programs, aligning clinical, CMC, and commercial objectives from early development through post-approval lifecycle management.\n\nProvide regulatory input to program governance, asset prioritization, and portfolio decisions, including scenario planning and risk mitigation.\n\nAnticipate and address regulatory challenges related to cell therapy development, manufacturing, comparability, and long-term follow-up.\n\n\n\n \nHealth Authority Engagement & Negotiations\n\nServe as the primary senior regulatory interface with FDA, EMA, and other global health authorities.\n\nLead and/or support key regulatory meetings, including INTERACT, pre-IND, End-of-Phase, pre-BLA/MAA, Advisory Committees, and post-marketing commitments.\n\nDrive regulatory negotiation strategy, including benefit-risk, endpoints, comparability, and post-approval requirements.\n\n\n\n \nLabeling Strategy & Commercial Readiness\n\nOwn and drive labeling strategy from early development through approval, ensuring labels support commercial differentiation, patient access, and lifecycle value.\n\nLead development of Target Product Profiles (TPPs) and ensure alignment across Clinical, Regulatory, Commercial, and Market Access.\n\nPartner with Commercial, Medical Affairs, and Market Access to ensure regulatory decisions support launch readiness, promotional strategy, and payer engagement.\n\nLead label negotiations with health authorities, balancing scientific evidence, regulatory expectations, and commercial objectives.\n\n\n\n \nRegulatory Submissions & Execution\n\nOversee and contribute to the preparation, review, and submission of INDs, CTAs, BLAs/MAAs, briefing packages, orphan drug applications, and other regulatory filings.\n\nEnsure submissions are high-quality, compliant, and strategically positioned.\n\nMaintain oversight of submission timelines, dependencies, and risk management, providing clear communication to senior leadership.\n\n\n\n \nCross-Functional & External Collaboration\n\nAct as a strategic partner to Clinical Development, CMC, Research, Commercial, Legal, BD, and Alliance Management teams.\n\nProvide regulatory due diligence and strategic input for business development, in-licensing, out-licensing, and partnership opportunities.\n\nOversee regulatory activities performed by CROs, consultants, and partners, ensuring quality and strategic alignment.\n\n\n\n \nTeam Development & Operational Excellence\n\nLead, mentor, and scale a high-performing regulatory team, fostering accountability, development, and a culture of collaboration.\n\nEstablish and maintain regulatory policies, procedures, and infrastructure to support a growing, late-stage organization.\n\nStay current on US and global regulatory intelligence and communicate key implications to stakeholders.\n\n\n\n \n\n\nQualifications\n\nBachelor's degree in a scientific discipline required; advanced degree preferred.\n\n15+ years of progressive regulatory affairs experience in pharmaceutical or biotechnology, with significant advanced therapy experience.\n\nCell and/or gene therapy experience preferred; autoimmune disease experience highly preferred.\n\nDemonstrated success leading global regulatory strategies through late-stage development and/or approvals, ideally including BLA/MAA experience.\n\nProven experience with labeling strategy development and negotiation, with strong understanding of commercialization impacts.\n\nDeep knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks; EMA and ex-US experience preferred.\n\nTrack record of effective engagement with FDA OTP and/or divisions overseeing autoimmune or immune-mediated diseases.\n\nStrong executive communication skills with the ability to influence senior leadership and Board-facing audiences.\n\nDemonstrated ability to lead and scale teams in a fast-paced, high-growth environment. Prior supervisory experience preferred. \n\nStrategic mindset with the ability to balance scientific rigor, regulatory compliance, and commercial impact.\n\n\n\n\n\n\n\n\n\nThe national base salary range for this position is $270K-$300K annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors that may include but are not limited to quality and length of experience, education, geographic location and alignment with market data. This position is also eligible for bonus, benefits, and participation in the company's stock plan.\n\n \n\n#Location\nRemote