岗位职责要求

Job Mission:

Participates in the preparation and execution of regulatory projects necessary to achieve successful registration of company products in order to support business goals and corporate objectives. Responsible for regulatory interactions and negotiations with internal and external departments.

Main Responsibilities:

1. Implement regulatory strategy and day-to-day operations for FSMP products.

2. Ensure FSMP registration dossier readiness and registration approval on time and maintain the license.

3. Undertake interactions and negotiations with Regulatory Authorities to secure and optimize regulatory approvals concordant with strategic company goals.

4. Be sensitive to the regulatory environment change and support to identify regulatory risks and challenges, and develop strategies and backup plans to address them.

5. Maintain an up-to-date knowledge of regulatory affairs policies and guidelines.

6. Ensure products compliance in terms of China regulatory requirements.

7. Share regulatory requirement with cross function to support business sustainable growth.

Regulatory Affairs Manager