Regulatory Affairs Director

1 month ago


Beijing, Beijing, China Bayer Full time

At Bayer, we're driven to solve the world's toughest challenges and strive for a world where health for all and hunger for none is a real possibility.

Associate RA CMC Director

Your Key Responsibilities

  • Develop and implement strategies for marketed chemical and bio-products in China, including dossier preparation, QC testing, and timely tracking of project status.
  • Mentor junior colleagues to achieve regulatory objectives and provide insight to projects handled by other CMC colleagues.
  • Serve as a primary contact person with Health Authorities for CMC technical review, ensuring timely updates and appropriate actions.
  • Interact with CRT, GRT, and Global Regulatory CMC/Global Product Supply to provide local know-how and form an aligned regulatory strategy.
  • Participate in policy making via Bayer and industry platforms, providing insight on new regulations and policies.
  • Ensure compliance with Company internal policies, systems, and databases, as well as local regulations.

Requirements

  • Advanced technical degree (Ph.D., D.V.M., or Pharm.D.) in life sciences with 6 years of regulatory experience or MS with 8 years of regulatory experience or BS with 10 years of regulatory experience.
  • Deep knowledge of local regulations, guidance, and familiarity with other agency's regulations.
  • Good communication skills, verbal and written, and ability to work within a global team framework.
  • Strong analytical skills and demonstrated problem-solving as applied to local regulatory issues.


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