Novo Nordisk A/S • Beijing, Beijing, China • Posted June 17, 2026
Location
Beijing, Beijing
Job Type
Full-time
Category
Operations Specialties Managers
Posted
June 17, 2026
Key responsibilities
CMC Regulatory Strategy and Change ManagementManufacturing and Testing Practice (MTP) EstablishmentCMC Technical Assessment and Regulatory SupportSubmission and Approval of Marketed Product MaintenanceRegulatory Compliance and SystemRegulatory Policy Influence and AdvocacyCross Function/Department SupportingMain job tasks
CMC Regulatory Strategy and Change ManagementFacilitate the development and execution of phase-appropriate CMC regulatory strategies for China submissions, ensuring timely approvals and alignment with both global strategy and local regulatory expectations.Proactively identify documentation requirements and assess regulatory risks, enabling efficient submission planning and minimizing approval delays.Lead regulatory evaluation of CMC changes and provide strategic guidance to project teams, ensuring robust change management and sustained product co...
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