Job Description
Key responsibilitiesCMC 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 Supporting Main 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 compliance.Continuously refine regulatory strategies based on evolving project needs, regulatory feedback...