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CMC Associate Manager

🏢
Novo Nordisk A/S
📍 Beijing, China
📍
Location Beijing
📅
Posted June 01, 2026
🚗
Commute Local Area
🎯
Local Opportunity Near You!

This job is in your area. Enjoy a short commute and work close to home.

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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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    📍 Location Details

    🌆
    City
    Beijing
    🗺️
    Country
    China
    🚗
    Commute
    Local Area

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