Senior Director, Regulatory Strategy

Job description

Role Summary The Senior Director, Regulatory Strategy will provide global regulatory leadership for AAV gene therapy development programs with an emphasis on early-stage clinical development. This role is responsible for defining and executing integrated regulatory strategies that align with corporate objectives, development timelines, and evolving global regulatory expectations for gene therapy products. The ideal candidate will have deep experience leading global regulatory programs and extensive interaction with FDA, EMA, and other major health authorities. Strong preference will be given to candidates who also have regulatory CMC experience that could fill a dual role leading regulatory CMC. Primary Responsibilities: - Function as the global regulatory lead for early stage programs and participate in and advise global development teams - Define and lead the Regulatory strategy for early-stage gene therapy programs (pre-IND through Phase 1/2) - Lead preparation for and participation in global health authority interactions, including FDA (CBER), EMA, and other regional agencies - Lead the strategy and preparation of key regulatory objectives and documents such as Fast Track, RMAT...