Associate Director, RA CMC

Role: Associate Director of Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC), leading strategic regulatory planning and submissions for biopharmaceutical products. Responsibilities: develop and manage CMC regulatory strategies for INDs, CTAs, marketing applications, and variations; prepare and review regulatory submissions; serve as liaison with agencies like the FDA; oversee change control processes; contribute to cross-functional teams such as product development and global regulatory groups; stay current on regulations, and lead internal policies and initiatives. Requirements: Bachelor's in Pharmacy, Chemistry, Biology, Pharmacology, Engineering, or related; 8+ years in pharma, with at least 3 years in leadership; experience in developing global regulatory strategies, working with health authorities, and navigating complex matrix environments; strong communication skills. Preferred: Advanced degree, relevant certifications, 10+ years industry experience including R&D or manufacturing. High-Value: Focus on biopharma CMC regulatory strategy, experience with agency interactions, and change management, supporting pharmaceuticals at various stages (preclinical/IND/clinical). Collaboration: Works with internal departments (R&D, Operations) and external agencies. Work Setup: Not specified.