Director, Regulatory Affairs CMC

Role: The Director of Chemistry Manufacturing Controls (CMC) leads global regulatory strategies for small molecule investigational and marketed products, overseeing CMC activities, health authority negotiations, and submission content. Responsibilities include developing and implementing regulatory CMC plans, managing a team, ensuring compliance with global requirements (FDA, EMA, ICH), and driving digital and AI-enabled process innovations. The role involves strategic risk assessment, stakeholder influence, and continuous improvement initiatives. Qualifications: Bachelor’s in life sciences; advanced degree preferred; 10+ years in pharma/biotech supporting small molecule development; 3+ years in leadership; proven record in global CMC regulatory strategy, major submissions, and health authority interactions. High-Value: Small molecule portfolio, regulatory leadership, AI/digital innovation, global compliance, cross-functional collaboration, hybrid work setup with onsite flexibility.