Associate Director/Director, Regulatory Strategy

Role: Associate Director/Director of Regulatory Strategy leading global regulatory initiatives for Rapport's lead program, RAP-219, targeting bipolar disorder. Responsibilities: develop and execute regulatory strategies for late-stage drug development, manage and maintain INDs, CTAs, and NDAs, advise cross-functional teams on clinical plans, trial design, and safety, and serve as primary contact with health authorities including FDA and EMA. Requirements: bachelor’s in a life science; 8-10 years of pharma/biotech regulatory affairs experience, with a focus on small molecule CNS drug development and global regulatory processes; strong leadership, communication, and cross-functional influence skills. HighValue: CNS indications (bipolar, epilepsy), small molecule development, global regulatory engagement, late-stage clinical programs, experience with FDA/EMA interactions, regulatory application maintenance, and GxP compliance. WorkSetup: hybrid in Boston, onsite Monday-Wednesday, with potential for remote work.