Director, Regulatory CMC

Role: Director of Regulatory CMC leading global strategies for Chemistry, Manufacturing, and Controls across all product stages from discovery to post-approval. Responsibilities: develop and execute lifecycle CMC regulatory plans, author and review technical documentation for global submissions (INDs, NDAs, supplements), evaluate complex manufacturing and analytical changes, coordinate with internal teams and external partners, lead interactions with regulatory authorities, and ensure compliance with ICH, FDA, EMA, NMPA, and other global standards. Qualifications: advanced degree in chemistry, pharmaceutical sciences, or chemical engineering; 10+ years in pharma, with substantial experience in regulatory CMC, small molecule development, and global submissions. Preferred: expertise in clinical-stage and commercial CMC strategies, strong cross-functional influence, and experience with multiple regulatory agencies. HighValue: focus on small molecules, clinical development, lifecycle management, global regulatory compliance, and cross-functional collaboration with quality, manufacturing, and clinical teams. WorkSetup: not specified, but implied to be a senior leadership role with extensive cross-departmental interaction.