Role Overview for VP, Regulatory Affairs with a Gene Therapy Company – San Francisco, CA
JRG Partners is proud to partner with a pioneering, clinical-stage gene therapy company based in the vibrant biotechnology hub of San Francisco, CA. Our client is dedicated to developing potentially curative, one-time treatments for severe genetic diseases with high unmet medical need. They are seeking a visionary and strategic Vice President of Regulatory Affairs to join their executive leadership team. This is a paramount role responsible for conceiving, developing, and executing the global regulatory strategy for the company’s entire portfolio, from early-stage development through to commercialization.
As the VP of Regulatory Affairs, you will be the principal architect of the company’s regulatory roadmap, serving as the primary liaison with global health authorities, including the FDA, EMA, and others. You will provide critical regulatory insights and leadership to cross-functional teams, ensuring that all development programs are designed and executed in compliance with the highest global standards. This position offers a unique opportunity to make a profound impact on the lives of patients by guiding novel gene therapies through the complex regulatory landscape and bringing them to market. The ideal candidate will be a seasoned leader with a deep understanding of the regulatory intricacies of biologics and gene therapies, a proven track record of successful major submissions, and the passion to build and mentor a world-class regulatory affairs team.
This role demands a unique blend of scientific acumen, strategic foresight, and exceptional leadership. You will be instrumental in shaping the company’s future, influencing key development decisions, and navigating the evolving challenges and opportunities in the field of gene therapy. If you are a transformative leader eager to apply your expertise in a dynamic, science-driven environment, we invite you to consider this exceptional opportunity.
Key Responsibilities of VP, Regulatory Affairs with a Gene Therapy Company – San Francisco, CA
Strategic Leadership
Develop, articulate, and execute innovative and forward-thinking global regulatory strategies for all products in the development pipeline, from preclinical stages through post-marketing commitments.
Health Authority Engagement
Act as the primary, high-level point of contact with global health authorities (e.g., FDA, EMA, PMDA). Lead the strategy, preparation for, and conduct of all major health authority meetings and interactions.
Regulatory Submissions
Provide executive oversight for the planning, preparation, review, and submission of high-quality regulatory filings, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), Biologics License Applications (BLAs), and Marketing Authorisation Applications (MAAs).
Team Development and Leadership
Recruit, lead, mentor, and develop a high-performing regulatory affairs team. Foster a culture of collaboration, excellence, and proactive problem-solving. Manage departmental budgets, resources, and external consultants.
Cross-Functional Collaboration
Serve as the regulatory subject matter expert on the executive leadership team and provide strategic counsel to cross-functional partners in Clinical Development, Nonclinical, CMC, Quality, and Commercial teams.
CMC Regulatory Affairs
Provide strategic regulatory guidance on all Chemistry, Manufacturing, and Controls (CMC) aspects of product development, ensuring alignment with global requirements for gene therapy products.
Regulatory Intelligence
Proactively monitor, interpret, and disseminate intelligence on the evolving global regulatory landscape. Analyze new regulations, guidance documents, and competitive precedents to inform and adapt company strategy.
Lifecycle Management
Develop and implement regulatory strategies for post-approval activities, including supplements, variations, annual reports, and management of regulatory commitments.
Compliance and Governance
Ensure that all company activities are conducted in compliance with GxP standards and applicable global regulations. Establish and oversee the Promotional Review Committee (PRC) to ensure all commercial and medical communications are compliant.
Due Diligence
Provide expert regulatory assessment and support for potential in-licensing, out-licensing, and other business development opportunities.
Requirements for the VP, Regulatory Affairs with a Gene Therapy Company – San Francisco, CA
Educational Background
An advanced degree (PhD, MD, PharmD) in a relevant life sciences discipline is required.
Professional Experience
A minimum of 15 years of progressive experience in the biotechnology or pharmaceutical industry, with at least 10 years in a dedicated regulatory affairs function.
Gene/Cell Therapy Expertise
A minimum of 5 years of direct, hands-on experience with the regulatory aspects of gene therapy, cell therapy, or other advanced therapy medicinal products (ATMPs) is essential.
Submission Track Record
Demonstrable experience leading the successful preparation and submission of a major marketing application (BLA/MAA) for a biologic product.
Leadership Experience
A minimum of 8 years of proven experience in a leadership role, with a strong track record of building, managing, and developing high-performing teams.
Global Health Authority Interaction
Extensive experience leading interactions and negotiations with the FDA (CBER) and EMA is mandatory. Experience with other global health authorities is highly desirable.
Regulatory Knowledge
An expert-level understanding of global regulatory frameworks, including deep familiarity with the FDA’s Cellular & Gene Therapy Products guidance and equivalent EMA regulations, is essential. Comprehensive knowledge of GxPs (GMP, GCP, GLP) and ICH guidelines is required.
Strategic Acumen
Exceptional ability to think strategically and critically, and to translate complex regulatory requirements into actionable, business-oriented strategies.
Communication Skills
Outstanding written and verbal communication skills, with the ability to effectively articulate complex regulatory issues to a variety of audiences, including executive leadership, board members, and regulatory agencies.
Personal Attributes
High emotional intelligence, strong interpersonal skills, a collaborative mindset, impeccable integrity, and the ability to thrive in a fast-paced, innovative, and entrepreneurial environment.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a highly competitive compensation and benefits package, including:
- Competitive base salary, annual performance-based bonus, and a significant equity package (stock options).
- Comprehensive health, dental, and vision insurance for employees and their dependents.
- Generous 401(k) plan with a competitive company match.
- Substantial Paid Time Off (PTO) policy, including vacation, sick leave, and company holidays.
- Paid parental leave to support employees and their families.
- A professional development budget to support continuous learning, conference attendance, and career growth.
- A comprehensive wellness program, including a monthly stipend for gym memberships or other wellness activities.
- Relocation assistance for qualified candidates.
- A dynamic, collaborative, and science-focused company culture with a shared mission to help patients.
How to Apply
If you are a visionary regulatory leader ready to take on a pivotal role at the forefront of gene therapy, we encourage you to apply. To be considered for this transformative leadership opportunity, please submit your resume and a cover letter detailing your relevant experience.
JRG Partners is proud to be the exclusive recruitment partner for this critical search. We are a specialized executive search firm with a deep commitment to the life sciences sector. To learn more about our focused approach and successful placements within this dynamic industry, you can explore our expertise in Life Sciences executive search. We look forward to reviewing your application and discussing how your expertise can drive the success of our client’s mission.
