Associate Director, Regulatory CMC, Biologics

Role: Lead global regulatory CMC strategies for biologics, focusing on authoring and reviewing high-quality submissions (INDs, NDAs, BLAs, MAAs) and serving as primary interface with health authorities. Responsibilities: develop and execute CMC regulatory strategies, oversee lifecycle management, assess changes and deviations, guide cross-functional teams, and drive digital and AI-enabled process improvements. Requirements: Bachelor's in life sciences; 8+ years in biopharma with biologics, demonstrated expertise in CMC regulatory submissions and health authority interactions; strong knowledge of FDA, EMA, ICH regulations. Preferred: advanced degree, experience with complex/multi-product biologics, digital tools, structured content, and automation. High-Value: biologics, regulatory submissions, digital/AI tools, global health authority engagement, lifecycle management. Work Setup: hybrid or on-site; flexible work arrangements.