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CMC Associate Manager

📍 Novo Nordisk A/S • Beijing, Beijing, China • Posted June 08, 2026

Full-time Posted June 08, 2026
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Job Description

Key responsibilities

  • CMC Regulatory Strategy and Change Management
  • 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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