Executive Director, Regulatory Affairs (Remote) at Kyverna Therapeutics | Lead Global Cell Therapy Regulatory Strategy
The biotechnology industry is advancing rapidly, particularly in cell and gene therapies that have the potential to transform treatment for complex diseases. As these innovative therapies move through clinical development toward commercialization, experienced regulatory leaders play a critical role in ensuring compliance, securing approvals, and bringing life-changing medicines to patients worldwide.
Kyverna Therapeutics is hiring an Executive Director, Regulatory Affairs for a full-time remote position, with a preference for candidates who can work West Coast U.S. hours. This executive leadership opportunity is ideal for seasoned regulatory affairs professionals with deep expertise in advanced therapies, global health authority engagement, and commercialization strategy.
About Kyverna Therapeutics
Kyverna Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative cell therapies for patients living with autoimmune diseases. The company's mission is to transform the treatment of autoimmune conditions through next-generation CAR T-cell therapies designed to provide long-lasting disease control.
Its clinical pipeline includes investigational therapies for conditions such as lupus nephritis, multiple sclerosis, myasthenia gravis, systemic sclerosis, and stiff person syndrome. By combining scientific innovation with patient-centered care, Kyverna is helping shape the future of autoimmune disease treatment.
About the Role
The Executive Director of Regulatory Affairs will provide strategic and operational leadership across Kyverna's global regulatory activities. Reporting to the Senior Vice President and Chief Regulatory Officer, the successful candidate will lead regulatory strategy from early clinical development through product approval and commercialization.
This position requires close collaboration with Clinical Development, CMC (Chemistry, Manufacturing and Controls), Commercial, Medical Affairs, Legal, Market Access, and Business Development teams to ensure regulatory strategies support both scientific excellence and commercial success.
Key Responsibilities
Lead Global Regulatory Strategy
The Executive Director will:
- Develop global regulatory strategies across Kyverna's cell therapy portfolio.
- Guide development programs from early research through commercialization.
- Support portfolio prioritization and regulatory planning.
- Identify regulatory risks and mitigation strategies.
- Align regulatory objectives with business goals.
Manage Health Authority Engagement
The role includes serving as Kyverna's primary regulatory representative with agencies such as:
- U.S. Food and Drug Administration (FDA).
- European Medicines Agency (EMA).
- Other international regulatory authorities.
Responsibilities include leading regulatory meetings, negotiating approval strategies, and supporting regulatory inspections.
Drive Labeling Strategy
You'll oversee product labeling activities by:
- Developing Target Product Profiles (TPPs).
- Leading label negotiations.
- Supporting commercialization strategies.
- Collaborating with Market Access and Commercial teams.
- Ensuring labeling aligns with regulatory requirements and patient needs.
Oversee Regulatory Submissions
Key submission responsibilities include preparing and reviewing:
- Investigational New Drug (IND) applications.
- Clinical Trial Applications (CTAs).
- Biologics License Applications (BLAs).
- Marketing Authorization Applications (MAAs).
- Orphan Drug Designation requests.
- Regulatory briefing documents.
Ensuring submission quality and timely delivery will be a core responsibility.
Collaborate Across Departments
You'll partner with teams including:
- Clinical Development.
- Manufacturing (CMC).
- Research.
- Commercial.
- Legal.
- Business Development.
- Alliance Management.
Strong cross-functional leadership is essential to achieving regulatory and commercial milestones.
Build and Mentor Regulatory Teams
The Executive Director will:
- Lead and develop a high-performing regulatory organization.
- Mentor regulatory professionals.
- Establish operational procedures.
- Promote continuous improvement.
- Maintain awareness of evolving global regulatory requirements.
Required Qualifications
Qualified candidates should generally possess:
- Bachelor's degree in a scientific discipline (advanced degree preferred).
- 15+ years of progressive Regulatory Affairs experience.
- Significant experience within pharmaceutical or biotechnology companies.
- Strong background in advanced therapies, particularly cell or gene therapy.
- Experience leading global regulatory strategies through late-stage development and product approvals.
- Extensive FDA regulatory knowledge.
- Familiarity with ICH guidelines and global regulatory frameworks.
- Excellent executive communication and leadership skills.
- Experience managing and developing regulatory teams.
Preferred Qualifications
Candidates with the following experience will be especially competitive:
- Autoimmune disease expertise.
- Cell therapy development.
- Biologics License Application (BLA) experience.
- Marketing Authorization Application (MAA) experience.
- FDA Office of Therapeutic Products engagement.
- Commercial launch readiness.
- Regulatory negotiations.
- Global product lifecycle management.
Salary and Benefits
Kyverna Therapeutics offers a highly competitive executive compensation package, including:
- Base salary of $270,000–$300,000 USD per year.
- Annual performance bonus eligibility.
- Equity through the company's stock plan.
- Comprehensive health and wellness benefits.
- Remote work flexibility.
- Opportunities to work alongside leading experts in biotechnology and cell therapy.
Career Growth Opportunities
This executive leadership role can lead to positions such as:
- Vice President, Regulatory Affairs.
- Chief Regulatory Officer.
- Head of Global Regulatory Affairs.
- Executive Vice President, Development.
- Chief Development Officer.
Professionals with advanced therapy regulatory expertise remain in exceptionally high demand across the biotechnology industry.
Why Join Kyverna Therapeutics?
Joining Kyverna offers the opportunity to:
- Shape regulatory strategy for breakthrough autoimmune therapies.
- Lead global interactions with major regulatory agencies.
- Influence commercialization of innovative CAR T-cell therapies.
- Work alongside world-class scientists and healthcare professionals.
- Make a meaningful impact on patients living with autoimmune diseases.
- Help bring transformative treatments to global markets.
How to Apply
Interested candidates can submit their applications through Kyverna Therapeutics' official careers portal.
Application Link:
Before applying, update your resume to highlight your leadership experience in Regulatory Affairs, advanced therapy programs, global health authority interactions, BLA or MAA submissions, commercialization strategy, and cross-functional leadership. Demonstrating successful regulatory approvals and executive-level stakeholder management will significantly strengthen your application.
Final Thoughts
The Executive Director, Regulatory Affairs role at Kyverna Therapeutics is an exceptional opportunity for experienced biotechnology leaders who want to shape the future of autoimmune disease treatment.
With responsibilities spanning global regulatory strategy, health authority engagement, commercialization planning, and leadership of high-performing regulatory teams, this remote executive position offers outstanding compensation, meaningful scientific impact, and the opportunity to help bring innovative cell therapies to patients around the world.
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