Vice President, Regulatory Affairs Strategy Greater San Francisco, CA Area

The Company is seeking a Vice President of Regulatory Affairs Strategy to lead global regulatory planning for gene therapy programs from early clinical development through marketing approval. The role will shape development and submission strategies across major markets, guide regulatory direction on program and governance teams, and lead interactions with health authorities. Responsibilities include overseeing major regulatory submissions, advising cross-functional teams on evidence generation and manufacturing considerations, and identifying appropriate expedited pathways. The successful candidate will also lead and develop the regulatory strategy team, communicate risks and recommendations to senior leadership, and support regulatory readiness and business development activities. Candidates must hold a bachelor’s degree in life sciences or a related discipline; an advanced degree is preferred. Extensive biopharmaceutical or biotechnology experience is required, with the required years varying by degree, alongside substantial Regulatory Affairs experience and at least eight years of people-management experience. Experience in viral vector gene therapy and direct work with the relevant U.S. regulatory authority are required; AAV expertise is highly desirable. Candidates should have senior-level ownership of a successful biologics or advanced-therapy marketing application and a record of developing global strategies, negotiating development plans, and preparing regulatory submissions. Expert knowledge of international regulations, strong scientific and regulatory writing, sound judgment, and effective cross-functional leadership are essential.

Hiring Company

4D Molecular Therapeutics