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.