Manufacturing and Testing Practice (MTP) Establishment
CMC Technical Assessment and Regulatory Support
Submission and Approval of Marketed Product Maintenance
Regulatory Compliance and System
Regulatory Policy Influence and Advocacy
Cross Function/Department Supporting
Main job tasks
CMC Regulatory Strategy and Change Management
Facilitate 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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