Associate Director, Regulatory Starting Material

Role: Associate Director, Regulatory Starting Material leading strategy and justification for RSM selection related to drug substance manufacturing for late-stage clinical and commercial programs. Responsibilities: develop and defend RSM strategies per ICH Q11, manage resupply and scale-up activities, author and review regulatory submissions, lead health authority interactions, evaluate synthetic routes and impurity profiles, oversee technology transfer, manage relationships with CMOs and suppliers, monitor evolving guidance, support cross-functional collaboration, and mentor a team. Requirements: PhD in chemistry or chemical engineering; 8-10 years in CMC, process chemistry, or drug substance development/manufacturing; proven experience supporting late-stage clinical or commercial programs; expertise in ICH Q11 and regional guidance; strong scientific writing and communication skills; experience with CMO management and GMP standards. HighValue: focus on drug substance/CMC, late-stage clinical/marketed products, regulatory strategy, synthetic route evaluation, impurity control, cross-functional collaboration, and global supply chain oversight. WorkSetup: US-based, with occasional travel (~10-20%).