Associate Director, CMC Regulatory Affairs

The Associate Director, CMC Regulatory Affairs executes multi-product global regulatory CMC strategies for investigational and marketed products, leading the preparation and filing of regulatory submissions while managing interactions with Health Authorities. This role provides regulatory guidance to cross-functional teams, ensures compliance with global regulatory requirements, and may supervise other regulatory staff. The position involves strategic planning, problem-solving, and advanced knowledge of FDA, EMA, Health Canada, and ICH guidelines.