Role Overview for VP, Regulatory Strategy with a Gene Therapy Company – San Francisco, CA
JRG Partners is proud to partner exclusively with a pioneering, clinical-stage gene therapy company based in the vibrant biotechnology hub of San Francisco, CA. Our client is dedicated to developing transformative, one-time curative treatments for patients with severe genetic disorders. With a robust pipeline and cutting-edge science, they are at the forefront of genetic medicine. We are seeking a visionary and experienced Vice President of Regulatory Strategy to join their executive leadership team.
This is a career-defining opportunity for a strategic leader to architect and execute the global regulatory vision for the company’s entire portfolio. The VP, Regulatory Strategy will be the central figure in navigating the complex and evolving landscape of gene therapy regulations. You will serve as the primary liaison with global health authorities, including the FDA, EMA, and other key international bodies. This role requires a leader who can seamlessly blend deep scientific understanding with astute regulatory acumen, providing critical guidance to cross-functional teams from discovery through commercialization.
Reporting directly to the Chief Medical Officer, you will be responsible for building and mentoring a world-class regulatory affairs team. Your leadership will be instrumental in shaping the development pathways for novel therapeutic candidates, ensuring timely and successful submissions, and ultimately, bringing life-altering therapies to patients in need. The ideal candidate is a strategic thinker, a compelling communicator, and a collaborative leader with a proven track record of success in the biologics space, particularly with advanced therapy medicinal products (ATMPs). You will be empowered to make a significant impact on the company’s trajectory and the future of genetic medicine.
Key Responsibilities of VP, Regulatory Strategy with a Gene Therapy Company – San Francisco, CA
Global Regulatory Strategy Development
Conceive, develop, and implement innovative and forward-thinking global regulatory strategies for all pipeline products, from pre-clinical development through post-marketing commitments. Ensure strategies are aligned with business objectives and are optimized for expedited pathways where appropriate.
Health Authority Engagement
Act as the company’s primary point of contact with global health authorities. Lead the strategy, preparation for, and execution of all major health authority interactions, including pre-IND, End-of-Phase, pre-BLA/MAA meetings, and advisory committee meetings. Foster and maintain strong, collaborative relationships with regulators.
Regulatory Submissions Leadership
Provide executive oversight for the planning, preparation, review, and submission of all regulatory filings. This includes Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), Orphan Drug Designations (ODDs), and major marketing applications like Biologics License Applications (BLAs) and Marketing Authorisation Applications (MAAs).
Team Leadership and Development
Build, lead, and mentor a high-performing regulatory affairs department. Foster a culture of excellence, collaboration, innovation, and accountability. Provide strategic guidance, professional development, and mentorship to team members.
Cross-Functional Collaboration
Serve as the regulatory subject matter expert on cross-functional development teams. Collaborate closely with Clinical Development, Nonclinical, CMC, Quality Assurance, and Commercial leaders to provide strategic regulatory input and ensure alignment across all functions.
Regulatory Intelligence and Policy
Proactively monitor, interpret, and analyze the evolving global regulatory landscape for gene therapies and rare diseases. Advise senior leadership on the potential impact of new regulations, guidances, and policies, and help shape the company’s external policy positions.
Compliance and Quality Oversight
Ensure all regulatory activities, documents, and submissions are of the highest quality and in full compliance with global GxP standards and applicable regulations. Partner with the Quality team to prepare for and manage health authority inspections.
Due Diligence and Business Development
Provide critical regulatory expertise and assessment for potential in-licensing, out-licensing, and partnership opportunities. Conduct regulatory due diligence to identify potential risks and opportunities.
Requirements for the VP, Regulatory Strategy with a Gene Therapy Company – San Francisco, CA
Educational Background
An advanced degree (PhD, MD, PharmD) in a relevant life sciences discipline is strongly preferred. A Bachelor’s or Master’s degree with extensive, directly relevant experience will be considered.
Professional Experience
A minimum of 15 years of progressive experience in the biotechnology or pharmaceutical industry, with at least 10 years dedicated to regulatory affairs.
Gene Therapy/Biologics Expertise
Must have significant experience with biologics. Direct, hands-on experience in the development of cell or gene therapies is highly required. Experience with rare disease indications is a significant plus.
Leadership Experience
Demonstrated track record of building and leading successful regulatory affairs teams in a dynamic, fast-paced environment. Previous experience at a Senior Director or Vice President level is essential.
Health Authority Interaction
Extensive, firsthand experience leading interactions with major global health authorities, particularly the FDA (CBER) and EMA. Proven ability to negotiate effectively and build consensus with regulators.
Major Submissions
A proven track record of successfully leading the strategy and execution of major marketing applications (BLA/NDA/MAA) resulting in approvals.
Strategic Acumen
Exceptional ability to think strategically and critically, and to translate complex regulatory requirements into actionable, business-oriented strategies.
Communication and Influence
Outstanding written and verbal communication skills. Must be able to articulate complex regulatory issues clearly to diverse audiences, including executive leadership, investors, and scientific teams. Strong influencing and negotiation skills are paramount.
Adaptability
Ability to thrive in a rapidly growing, entrepreneurial company environment. Must be comfortable with ambiguity and able to operate with a sense of urgency and a high level of integrity.
Benefits & Perks Offered
Our client is committed to investing in their employees and offers a comprehensive and competitive benefits package designed to support your health, well-being, and financial future. Benefits include:
Competitive Compensation
A highly competitive base salary, an attractive annual performance-based bonus, and a significant equity package (stock options) to ensure you share in the company’s long-term success.
Comprehensive Health and Wellness
Premium medical, dental, and vision insurance plans for you and your eligible dependents. Access to a Health Savings Account (HSA), Flexible Spending Accounts (FSA), and robust employee assistance programs.
Retirement Savings
A 401(k) retirement plan with a generous company matching contribution to help you save for the future.
Generous Time Off
A flexible and generous Paid Time Off (PTO) policy, in addition to paid company holidays and a year-end shutdown period to promote work-life balance and rejuvenation.
Family Support
Comprehensive paid parental leave policies for all new parents to support you and your growing family.
Professional Growth
A dedicated budget for professional development, including attendance at major industry conferences, workshops, and continuing education courses. Clear pathways for career advancement within a growing organization.
On-Site Perks
For our San Francisco-based team, we offer commuter benefits, catered lunches, a fully stocked kitchen with healthy snacks and beverages, and a modern, collaborative office space designed to foster innovation.
How to Apply
JRG Partners is the exclusive recruitment partner for this confidential search. To be considered for this pivotal leadership role, please submit your resume and a cover letter detailing your relevant experience and strategic vision. We are committed to a transparent and efficient interview process.
Our client is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
