CMC Regulatory Lead
2 months ago
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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