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# Director, Regulatory Affairs with a Gene Therapy Co. – San Francisco, CA



JRG Partners is proud to represent a pioneering, clinical-stage gene therapy company at the forefront of developing transformative treatments for rare and life-threatening genetic diseases. Based in the vibrant biotech hub of San Francisco, CA, our client is driven by a mission to harness the power of genetic medicine to create a future where these conditions are no longer a life sentence. Their innovative platform and robust pipeline are backed by world-class science and a leadership team with a proven track record of success.
As they advance their lead candidates through late-stage clinical development and towards commercialization, they are seeking a visionary and strategic leader to join their team as the Director of Regulatory Affairs. This is a unique opportunity to make a profound impact on the lives of patients and to shape the regulatory landscape for a new generation of medicines. You will be joining a passionate, collaborative, and science-driven culture where your expertise will be valued and your contributions will directly influence the company’s trajectory and success.
Role Overview for Director, Regulatory Affairs with a Gene Therapy Co. – San Francisco, CA
The Director of Regulatory Affairs will serve as a critical member of the leadership team, responsible for developing and executing comprehensive global regulatory strategies for the company’s portfolio of gene therapy products. This individual will be the primary point of contact with health authorities, including the FDA, EMA, and other international agencies. The Director will provide strategic regulatory guidance to cross-functional teams, ensuring that all development activities, from preclinical studies to post-market surveillance, are conducted in compliance with applicable regulations.
This role requires a deep understanding of the scientific and regulatory complexities of gene therapy, combined with exceptional leadership, communication, and strategic thinking skills. You will be instrumental in navigating the evolving regulatory environment, mitigating risks, and paving a clear path for successful product approvals worldwide. This position offers a significant leadership opportunity to build and shape the regulatory function within a dynamic, high-growth organization and to be at the center of bringing groundbreaking therapies to patients in need.
Key Responsibilities of Director, Regulatory Affairs with a Gene Therapy Co. – San Francisco, CA
Global Regulatory Strategy
Develop, lead, and execute innovative and robust global regulatory strategies for all pipeline products, from early-stage development through marketing authorization and lifecycle management. Ensure strategies are aligned with business objectives and are scientifically sound.
Health Authority Interactions
Act as the primary liaison between the company and global health authorities (e.g., FDA, EMA, PMDA). Lead the preparation for and execution of key meetings, including pre-IND, End-of-Phase, and pre-BLA/MAA meetings, fostering positive and productive relationships.
Regulatory Submissions
Oversee the planning, preparation, and submission of high-quality regulatory dossiers, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs), and all subsequent amendments and supplements.
Cross-Functional Leadership
Provide expert regulatory guidance and strategic input to cross-functional project teams, including Clinical Development, CMC (Chemistry, Manufacturing, and Controls), Nonclinical, and Commercial departments. Ensure that regulatory requirements are integrated into the overall development plans from the outset.
Regulatory Intelligence
Proactively monitor, interpret, and analyze the evolving global regulatory landscape for gene therapies. Assess the impact of new regulations, guidelines, and competitor activities on the company’s portfolio and communicate key intelligence to senior management and project teams. Your strategic insights must ensure all programs align with the latest FDA regulations for gene therapy products and international equivalents.
Compliance and Documentation
Ensure that all regulatory documentation is maintained to the highest standards of quality and compliance. Review and approve essential documents, including protocols, investigator brochures, clinical study reports, and CMC technical reports, for regulatory compliance and strategic alignment.
Team Leadership and Mentorship
Build, manage, and mentor a high-performing regulatory affairs team. Foster a culture of excellence, collaboration, and continuous learning, providing guidance and professional development opportunities to team members.
Promotional Material Review
Partner with the Commercial and Medical Affairs teams to provide regulatory review and approval of promotional materials, press releases, and other external communications to ensure compliance with applicable regulations.
Requirements for the Director, Regulatory Affairs with a Gene Therapy Co. – San Francisco, CA
Educational Background
An advanced degree (MS, PhD, PharmD, or MD) in a relevant life sciences discipline is required.
Professional Experience
A minimum of 10-12 years of progressive experience in regulatory affairs within the biotechnology or pharmaceutical industry. A significant portion of this experience must be with biologics, with direct, hands-on experience in cell and gene therapy being highly preferred.
Global Expertise
Demonstrated experience in leading the preparation and submission of major regulatory filings (INDs, CTAs, BLAs, MAAs). Proven track record of successful interactions and negotiations with major global health authorities, particularly the FDA (CBER) and EMA.
Strategic Acumen
Strong ability to think strategically and critically, analyzing complex issues and developing innovative solutions to regulatory challenges. Must be able to translate regulatory requirements into practical, workable plans for development teams.
Leadership and Influence
Proven leadership skills with experience in managing direct reports and leading cross-functional teams in a matrix environment. Must possess excellent interpersonal skills and the ability to influence and align stakeholders at all levels of the organization.
Communication Skills
Exceptional written and verbal communication skills are essential. The candidate must be able to articulate complex scientific and regulatory concepts clearly and persuasively to both technical and non-technical audiences.
Technical Knowledge
In-depth knowledge of US and international regulations and guidelines (GCP, GMP, GLP, ICH) governing the development of biologic products. Understanding of the specific regulatory challenges associated with AAV-based gene therapies is a significant plus.
Personal Attributes
A proactive, results-oriented individual with a high degree of integrity, a strong work ethic, and the ability to thrive in a fast-paced, dynamic, and collaborative start-up environment. Must be adaptable and able to manage multiple priorities effectively.
Benefits & Perks Offered
Our client is committed to investing in their employees and offers a highly competitive compensation and benefits package designed to attract and retain top talent. This includes:

A competitive base salary, annual performance-based bonus, and significant equity participation (stock options).
Comprehensive health, dental, and vision insurance for you and your eligible dependents.
A robust 401(k) retirement savings plan with a generous company match.
Generous paid time off (PTO), including vacation, sick leave, and company-paid holidays.
Support for professional development, including attendance at conferences and continuing education courses.
A collaborative, inclusive, and science-driven work culture with a clear mission.
Opportunity to work in a state-of-the-art facility in the heart of the San Francisco biotech community.
Relocation assistance may be available for exceptional candidates.

How to Apply
This is a retained search conducted by JRG Partners. If you are a strategic regulatory leader passionate about gene therapy and ready to make a tangible impact on patients’ lives, we encourage you to apply. To be considered for this pivotal role, please submit your resume and a cover letter detailing your relevant experience. For more information or to explore other opportunities within our specialized recruitment areas, please visit the JRG Partners’ Life Sciences practice page. We look forward to connecting with you and discussing how you can contribute to this exciting and mission-driven organization.