Associate Director, Regulatory Affairs - CMC

Role: Associate Director, Regulatory Affairs – CMC, leading global regulatory strategy for small molecule product development and registration. Responsibilities: develop and prepare CMC documentation for INDs, NDAs, and other submissions; manage lifecycle changes for commercial products, including manufacturing site changes and process improvements; collaborate cross-functionally with Regulatory Affairs, Technical Operations, and Quality; interpret regulatory guidance and provide strategic advice; support agency interactions and compliance activities. Requirements: Bachelor’s in a scientific discipline; 7-8+ years in pharmaceutical regulatory affairs or CMC technical writing; strong knowledge of small molecule development, ICH region regulations, and GMP standards; experience in global regulatory submissions (IND/CTA, NDA/MAA, NDS); excellent communication, collaboration, and project management skills; advanced degree preferred. High-Value: small molecule, global development, lifecycle management, post-approval CMC strategy, regulatory submissions, ICH/regulatory compliance. Work Setup: Up to 10% travel; location not specified but likely hybrid/onsite based on role scope.