CMC Regulatory Lead

2 months ago


Beijing, Beijing, China Bayer Full time
Your Key Responsibilities

At Bayer, we strive to make a significant impact on the world

Associate RA CMC Director

Key Tasks and Responsibilities

  • Regulatory Strategy and Planning
    • Develop and implement regulatory strategies for marketed chemical and bio-products, CTA, NDA in China.
    • Timely tracking and updating project QC testing and CMC review status.
    • Foreseeing potential CMC queries of HAs and taking appropriate actions.
  • Mentorship and Collaboration
    • Mentor junior colleagues to achieve pre-determine regulatory objectives.
    • Provide insight and contribute to projects handled by other CMC colleagues.
  • Health Authority Liaison
    • Serve as a primary contact person with HAs for CMC technical review for assigned products/projects.
    • Keep CRT timely informed about the status and take appropriate actions.
    • Manage and interact with Health Authority as liaison from regulatory CMC perspectives to ensure business growth.
  • Global Regulatory Alignment
    • Interact directly with CRT, GRT, Global Regulatory CMC/global Product Supply to provide in-depth local know-how.
    • Form an aligned best possible regulatory strategy among global and local stakeholders.
  • Policy Making and Contribution
    • Participate, support, and contribute to policy making via Bayer and industry platforms.
    • Provide insight of new regulations and policies.
  • General Topics and Compliance
    • Provide insight to projects and system users for general topics at China RA department level.
    • Ensure compliance of Company internal Policy/system/database/responsible projects and local regulation compliant behavior for assigned projects.


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