Manage preparation and execution of Chemistry, Manufacturing and Control documentation including Investigational New Drug Applications, Investigational Medicinal Product Dossiers, original Biologics License Applications, Marketing Authorization Applications, post-approval submissions/variations, agency meeting background packages, and responses to health authority questions. Required Experience and Skills: At least 5 years of Regulatory CMC or directly relevant pharmaceutical development experience in small molecules or other chemically synthesized modalities, including experience in process chemistry, analytical development, manufacturing, testing, quality, technical operations, or CMC product development.