Job description
This position, Senior Manager in Global Regulatory Affairs LCM-CMC, is a project-facing CMC position supporting life-cycle management. Key Responsibilities Regulatory Strategy & Execution Develop and implement global regulatory strategies for post-approval CMC changes. Assess regulatory impact of manufacturing, process, analytical, and supplier changes. Provide strategic CMC regulatory guidance to cross-functional teams (Quality, Manufacturing, Supply Chain, Analytical Development). Submission …