Associate Director, RA CMC

Role: Associate Director of Regulatory Affairs, CMC, overseeing global regulatory strategies for pharmaceutical products, including INDs, CTAs, and marketing applications. Responsibilities: develop and manage regulatory submission content; prepare for agency meetings and negotiate with agencies like the FDA; analyze regulatory information impacting product development; lead initiatives for policy and procedure development within RA CMC; collaborate with product development, operations, and regulatory teams; mentor and develop team members. Qualifications: Bachelor’s in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related field; 8+ years in pharma with at least 3 years in leadership; experience in global regulatory strategies, working with health authorities, and in complex matrix environments; strong communication skills. Preferred: advanced degree and certifications. High-Value: biopharma, CMC regulatory strategy, global filings, agency negotiations, and team leadership, with experience in complex pharma environments. Work setup: not specified; location and travel details not provided.