Associate Director, RA CMC

Role: Associate Director of Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC), focusing on strategic regulatory submissions and agency interactions to facilitate product approvals. Responsibilities: develop and manage CMC regulatory strategies for INDs, CTAs, marketing applications, supplements; prepare and review submissions; analyze regulatory information impacting decisions; lead agency meeting strategies and content; oversee change control processes; serve as liaison with agencies like the FDA; stay current on regulations and lead departmental initiatives; mentor team members. Requirements: Bachelor's in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related; 8+ years in pharma, including 3+ years in leadership; experience in global regulatory strategy development, working with health authorities, and navigating complex matrix environments; strong communication skills. Preferred: advanced degree, regulatory certifications, 10+ years pharma experience with R&D or manufacturing background. High-Value: focus on biologics or small molecules, CMC regulatory strategy, agency negotiations, global submissions, and GxP compliance. Work setup and travel details not specified.