Regulatory Affairs Director
1 month ago
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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