Associate Director, RA CMC

Role: Associate Director of Regulatory Affairs (CMC) responsible for developing and executing global regulatory strategies for pharmaceutical products, primarily focusing on CMC regulatory submissions and interactions with agencies like the FDA. Responsibilities: prepare and manage INDs/CTAs, amendments, marketing applications, and product change controls; develop strategies for agency meetings and represent CMC in cross-functional teams; analyze and interpret regulatory information and legislation; lead initiatives to improve regulatory processes; mentor staff and lead internal projects. Qualifications: Bachelor's degree in Pharmacy, Chemistry, Biology, Pharmacology, or related field; 8+ years in the pharmaceutical industry, including 3+ years in regulatory affairs or R&D/Manufacturing; strong experience with global regulatory strategies and agency interactions; excellent communication skills. Preferred: advanced degree or certifications; 10+ years’ experience; experience in regulated environments and complex matrix organizations. High-Value: focus on pharma development, regulatory submissions, and agency negotiations; expertise in CMC regulatory compliance and strategy; experience with INDs, CTAs, and global health authority interactions. WorkSetup: not specified, but involvement in cross-functional teams and strategic planning.