Associate Director, RA CMC

Role: Associate Director of Regulatory Affairs (CMC) responsible for developing and managing regulatory strategies for pharmaceutical products, including INDs, CTAs, marketing applications, and variations. Main objectives include ensuring first-pass approval, maintaining compliance, and fostering agency relationships. Responsibilities: prepare and oversee regulatory submissions, interpret technical data for regulatory decisions, develop strategies for agency meetings, manage manufacturing change controls, and lead internal initiatives on policies and procedures. Also involved in cross-functional team collaboration for product development and regulatory negotiations. Requirements: Bachelor's in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related field; 8+ years in pharma with at least 3 years in leadership roles; strong experience in global regulatory strategy development and working with health authorities. Preferred: Advanced degree, certifications, 10+ years pharma experience including R&D or manufacturing. High-value specifics: focus on CMC regulatory affairs within biopharma, experience with complex and matrix environments, and regulatory interactions with agencies such as FDA. Work setup details are not specified.