• Serve as the regulatory CMC representative on project teams. • Provides CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, Supply Chain and Regulatory colleagues, as well as third party laboratories, global collaborations partners and contract manufacturers. • Manage interactions with FDA and other global regulatory authorities for assigned project(s) to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information. • Author and lead CMC content for Health Authority meeting briefing packages, including development of CMC strategy, preparation of CMC-related questions, supporting data summaries, and responses to Health Authority feedback, in collaboration with Global Regulatory and cross-functional teams. • Develop and implement effective regulatory CMC strategies for global submissions knowing the life cycle of drug product from R&D through commercialization and can interpret and apply local regulations and guidance’s to the life cycle of a drug product. • Actively participate as a member of global regulatory teams and CMC subteams. • Support and manages regulatory aspects of CMC Operations including authoring, reviewing and or approving SOP’s, CAPA’s, etc.