Associate Director, RA CMC

Role: Associate Director of Regulatory Affairs, CMC, responsible for developing and executing regulatory strategies to support pharmaceutical product approvals and lifecycle management. Responsibilities include preparing and managing regulatory submissions such as INDs, CTAs, supplements, and variations; analyzing regulatory information; leading agency interactions and meetings; overseeing change control processes; and developing policies within the department. The role involves cross-functional collaboration with product development, global teams, and operations, serving as the strategic liaison with agencies like the FDA, and staying current on regulatory guidance and legislation. Requirements: a Bachelor's in Pharmacy, Chemistry, Biology, Pharmacology, or related field; 8+ years in pharma with at least 3 years in a leadership role; experience with global regulatory strategies, agency interactions, and working in complex matrix environments. Preferred: advanced degree, certifications, 10+ years pharma experience, especially in R&D, discovery, or manufacturing. HighValue: focus on CMC regulatory strategy, product lifecycle management, experience with biologics or small molecules, and agency negotiations. WorkSetup: not specified in the description.