Executive Director Regulatory Affairs
Kyverna Therapeutics
Description
Kyverna 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 whatâs possible.
Title: Executive Director, Regulatory Affairs
Location: Remote (West Coast hours preferred)
Reports to: SVP, Chief Regulatory Officer
Position Overview
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.
\nRegulatory 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.
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About Kyverna Therapeutics
Kyverna Therapeutics is a biotechnology company focused on developing innovative cell therapies. It utilizes a proprietary platform to engineer regulatory T cells for the treatment of autoimmune diseases.
Industry: Healthcare
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Interview Prep Guide
Preparation Strategy
To prepare for this role, focus on reviewing the current regulatory framework for cell therapies and practicing your ability to communicate complex regulatory concepts simply. Research the company's pipeline and recent regulatory submissions to understand their current regulatory landscape. Prepare examples of your experience with regulatory strategy and leadership, as well as your ability to build and maintain relationships with cross-functional teams. Review the company's core values and be ready to give examples of how you embody them.
Likely Interview Rounds
- 1. Screening call~30 min
What to prep: Review the company's pipeline and recent regulatory submissions to understand their current regulatory landscape. Prepare examples of your experience with regulatory strategy and leadership.
- What experience do you have in regulatory affairs, particularly in cell therapy?
- How do you stay current with changing regulatory requirements in the biopharmaceutical industry?
- 2. Technical~60 min
What to prep: Study the current regulatory framework for cell therapies, including relevant FDA guidelines and global regulations. Practice explaining complex regulatory concepts in simple terms.
- How would you approach regulatory strategy for a cell therapy product from early development through commercialization?
- What are some common regulatory challenges in cell therapy development, and how would you address them?
- 3. Behavioral~60 min
What to prep: Prepare examples of your experience working with regulatory authorities and cross-functional teams. Review the company's core values and be ready to give examples of how you embody them.
- Can you describe a time when you had to negotiate with a regulatory authority or resolve a regulatory issue?
- How do you build and maintain relationships with cross-functional teams, such as clinical, CMC, and commercial?
- 4. Final~90 min
What to prep: Research the company's competitors and the current state of the cell therapy industry. Prepare a thoughtful question for the final interview, such as 'What are the biggest regulatory challenges the company is currently facing, and how do you see this role contributing to addressing them?'
- What do you think are the most significant regulatory challenges facing the cell therapy industry, and how would you address them at Kyverna?
- How do you see yourself contributing to the company's mission and values as Executive Director of Regulatory Affairs?
Most Likely Questions
- What experience do you have with regulatory submissions and approvals?
- How do you stay current with changing regulatory requirements?
- Can you describe your experience with labeling strategy and health authority engagement?
- How do you build and maintain relationships with cross-functional teams?
- What do you think are the most significant regulatory challenges facing the cell therapy industry?
Common Pitfalls
- Lack of experience with cell therapy regulatory affairs
- Inability to communicate complex regulatory concepts simply
- Insufficient knowledge of current regulatory framework for cell therapies
- Poor relationships with cross-functional teams
Free Prep Resources
- • FDA guidelines for cell therapy products
- • EMA guidelines for advanced therapy medicinal products
- • Regulatory Affairs Professionals Society (RAPS) resources