Associate Director, RA CMC

Role: Associate Director of Regulatory Affairs, CMC, focusing on strategic regulatory submissions and compliance for pharmaceutical products. Primary objectives include developing and executing global CMC regulatory strategies to ensure first-pass approvals, managing submissions such as INDs, CTAs, and supplements, and serving as the liaison with regulatory agencies like the FDA. Core responsibilities encompass preparing and revising regulatory content, analyzing regulatory information, leading agency meetings, managing change controls, and influencing cross-functional teams to optimize regulatory outcomes. The role also involves policy development, internal initiatives, and mentoring team members. Requirements: Bachelor's degree in Pharmacy, Chemistry, Biology, Pharmacology, Engineering, or related field; 8+ years pharma experience with at least 3 years in a leadership role; experience developing global regulatory strategies and working with health authorities; strong communication skills. Preferred qualifications include advanced degrees and certifications. High-value specifics: experience with biologics or small molecules in complex, matrix environments; familiarity with FDA and global regulatory procedures; GxP knowledge; involvement in product development, manufacturing, and change management processes. The position may involve collaboration across R&D, manufacturing, and quality teams, with a focus on regulatory strategy and compliance. Work setup details are not specified.