Executive Director Regulatory Affairs
WFA Digital Insight
As the demand for cell therapies continues to grow, companies like Kyverna Therapeutics are at the forefront of innovation. With a 25% increase in cell therapy approvals over the past year, the need for experienced regulatory leaders has never been more pressing. This role requires a unique blend of strategic vision, technical expertise, and collaboration skills. Candidates with a strong background in regulatory affairs, particularly in the cell therapy space, will be well-positioned for success. Before applying, consider the evolving landscape of cell therapy regulation and the importance of effective health authority engagement.
Job Description
About the Role
The Executive Director, Regulatory Affairs will play a critical role in shaping the regulatory strategy for Kyverna Therapeutics' cell therapy portfolio. This includes leading the development of global regulatory plans, managing interactions with health authorities, and driving commercial readiness. The ideal candidate will have a deep understanding of the cell therapy landscape, as well as the ability to navigate complex regulatory environments.As a key member of the regulatory team, the Executive Director will work closely with cross-functional teams, including Clinical, CMC, Commercial, and Market Access. This role requires strong leadership skills, as well as the ability to build and maintain effective relationships with internal stakeholders and external partners.
Kyverna Therapeutics is committed to transforming the future of treatment for autoimmune diseases. As a patient-centered company, we are dedicated to developing innovative cell therapies that make a meaningful difference in the lives of patients. Our core values - Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome - guide our approach to regulatory affairs and our commitment to delivering high-quality, compliant, and strategically positioned regulatory submissions.
What You Will Do
- Lead the development of global regulatory strategies for Kyverna's cell therapy portfolio
- Manage interactions with health authorities, including the FDA and EMA
- Drive commercial readiness and labeling strategy for cell therapies
- Collaborate with cross-functional teams to align clinical, CMC, and commercial objectives
- Provide regulatory input to program governance, asset prioritization, and portfolio decisions
- Anticipate and address regulatory challenges related to cell therapy development, manufacturing, and long-term follow-up
- Lead the preparation, review, and submission of regulatory filings, including INDs, CTAs, and BLAs/MAAs
- Maintain oversight of submission timelines, dependencies, and risk management
- Act as a strategic partner to Clinical Development, CMC, Research, Commercial, Legal, BD, and Alliance Management teams
What We Are Looking For
- 10+ years of experience in regulatory affairs, with a focus on cell therapy or advanced therapies
- Strong understanding of regulatory requirements for cell therapies, including FDA and EMA guidelines
- Proven track record of successfully navigating complex regulatory environments
- Excellent leadership and collaboration skills, with the ability to build and maintain effective relationships with internal stakeholders and external partners
- Strong analytical and problem-solving skills, with the ability to think critically and strategically
- Experience with regulatory submissions, including INDs, CTAs, and BLAs/MAAs
- Strong communication and negotiation skills, with the ability to effectively interact with health authorities and other stakeholders
Nice to Have
- Experience with regulatory affairs in the biopharmaceutical industry
- Knowledge of clinical trial design and management
- Familiarity with FDA and EMA regulations and guidelines
- Experience with labeling strategy and commercial readiness
- Certification in regulatory affairs, such as RAC
Benefits and Perks
- Competitive salary and benefits package
- Opportunity to work with a innovative and patient-centered company
- Collaborative and dynamic work environment
- Professional development and growth opportunities
- Flexible working hours and remote work options
- Access to cutting-edge technologies and resources
- Comprehensive health insurance and wellness programs
How to Stand Out
- Develop a strong understanding of the current regulatory landscape for cell therapies, including FDA and EMA guidelines
- Highlight your experience with regulatory submissions, including INDs, CTAs, and BLAs/MAAs
- Emphasize your ability to navigate complex regulatory environments and build effective relationships with health authorities
- Showcase your analytical and problem-solving skills, with examples of how you have successfully addressed regulatory challenges
- Prepare to discuss your experience with labeling strategy and commercial readiness, as well as your understanding of clinical trial design and management
- Be ready to provide specific examples of your leadership and collaboration skills, including your ability to build and maintain effective relationships with internal stakeholders and external partners
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