Associate Director, Regulatory Strategy

Role: Associate Director, Regulatory Strategy at Rapport Therapeutics, focusing on developing regulatory pathways for small-molecule neuromedicines targeting conditions like focal epilepsy, PGTCS, and bipolar disorder. Responsibilities: create and execute regulatory strategies, advise cross-functional teams (clinical, CMC, pharmacology, nonclinical), manage regulatory applications (INDs, CTAs, NDAs), identify risks, lead regulatory interactions with authorities, ensure compliance with global requirements, and mentor junior staff. Requirements: Bachelor's in life sciences, 10+ years in pharma/biotech, experience in neurology and small molecules preferred, global drug development expertise, strong leadership, communication, and project management skills. HighValue: small molecule therapeutics, neuroscience/neuropsychiatry indications, early to late clinical development phases, regulatory submissions, international scope. WorkSetup: hybrid in Boston, onsite Mon-Wed; collaborative environment with leadership exposure.