Associate Director, RA CMC

Role: Associate Director of Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC), focusing on developing and executing regulatory strategies for biotech products. Responsibilities: prepare and manage regulatory submissions (INDs, CTAs, supplements), develop strategies for agency meetings, review data presentations, and oversee change control and product lifecycle activities. Serve as liaison with agencies like FDA, represent CMC on cross-functional teams, and lead initiatives to enhance regulatory processes. Qualifications: Bachelor's in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related; 8+ years in pharma with at least 3 years in leadership; experience in global regulatory strategy development, agency interactions, and working in complex matrix environments. Preferred: advanced degree, certifications, 10+ years pharma experience including R&D or manufacturing, strong communication skills. High-Value: expertise in biologics or small molecules, experience with global regulatory agencies, product lifecycle management, and regulatory strategy for CMC. WorkSetup: not specified; location and travel not detailed.