Senior Director, Regulatory CMC

Role: Senior Regulatory CMC Leader responsible for developing and implementing global regulatory strategies for Rapport's neuromedicines pipeline, including RAP-219 for epilepsy and bipolar disorder. Responsibilities: lead CMC content development for global submissions, guide cross-functional teams across manufacturing, quality, analytical, and lifecycle activities, support interactions with health authorities (FDA, EMA), evaluate CMC changes, and build the regulatory CMC function. Requirements: Bachelor's in a scientific discipline, 12+ years in biotech/pharma regulatory CMC with extensive late-stage/global registration experience; strong knowledge of FDA, EMA, ICH, and global CMC regulations; proven success supporting INDs/MAAs, NDAs, or MAAs, and engaging with health authorities. Preferred: neuroscience or biologics experience, NDA/MAA and commercialization involvement, technical CMC expertise. High-Value: leadership in late-stage development, global regulatory submission strategy, cross-functional collaboration, regulatory lifecycle management, focus on neuromedicines. Work Setup: based in Boston with onsite presence Monday-Wednesday; hybrid work environment.