Vice President, Regulatory Strategy & CMC Greater Boston, MA Area

The Company is seeking a Vice President for Regulatory Strategy and CMC. The successful candidate will be responsible for leading the development and execution of global regulatory and CMC strategies across the product portfolio. This includes providing strategic direction for regulatory interactions, product development, manufacturing, quality, and commercialization activities to support clinical development, regulatory approvals, and lifecycle management. The role involves leading cross-functional collaboration and serving as the primary executive advisor on regulatory and CMC risks, opportunities, and policy considerations. The VP will also be involved in organizational leadership, fostering a science-driven and compliance-focused culture, and influencing company strategy. Candidates for this role at The Company should have a Ph.D., Pharm.D., M.S., or advanced scientific degree in a relevant discipline, with at least 12 years of experience in the biotechnology, pharmaceutical, or cell and gene therapy industries, and a minimum of 6 years in a leadership capacity. Deep expertise in global regulatory affairs and CMC development is essential, as is a proven track record of leading major regulatory submissions and health authority interactions. The role requires significant experience in managing multiple development programs, building and managing multidisciplinary teams, and a strong background in commercialization and lifecycle management. Critical competencies include executive presence, risk assessment, cross-functional influence, and change management.

Hiring Company

Stoke Therapeutics