• Support development and execution of global CMC regulatory strategies for investigational and commercial small molecule and ASO programs, under the direction of the Senior Director • Author, compile, and review CMC sections of regulatory submissions, including INDs, IMPDs, NDAs, BLAs, amendments, and post-approval supplements • Coordinate CMC content development with Quality, Analytical, Development, and Commercial Manufacturing teams to ensure accuracy, alignment, and readiness for submission • Support and participate in health authority interactions, including preparation of briefing documents, responses to information requests, and meeting logistics • Maintain regulatory compliance for CMC activities supporting clinical supply, commercial manufacturing, and ongoing product supply, including stability updates and annual reports • Assist with post-approval change management, including comparability assessments, manufacturing changes, and technology transfers • Manage and coordinate external consultants, CMOs, CROs, and regulatory vendors supporting CMC regulatory activities