職位描述
POSITION SUMMARY
Reporting to the Senior Regulatory Affairs Manage, works with a team of regulatory affairs professionals to ensure establishes best practices within the assigned area of responsibility. E.g. CFDA Pre-market approval submission & regulatory reporting, design controls for new product development, technical standards, collection and dissemination of intelligence, influencing the global regulatory environment, etc.
KEY RESPONSIBILITIES
1. Prepare pre-market submissions (including type testing, registration files etc.) and obtain approval of premarket product registration timely.
2. Acts as the Regulatory partner for the BU he/she is responsible for.…
3. Interact with CFDA on registration requirements and monitor changes to requirements.
4. Independently manages and provide regulatory guidance to multiple long-term projects without direct supervision.
5. Manages a single discipline within the unit on a project or short-term basis.
6. Interacts with manager as required by specific issues, milestones, or status changes.
7. Represents BD externally in long term project in specific fields.
8. Accepts accountability for RA within BD on multi disciplinary platforms.
9. Manages the regulatory review of labels, labeling, promotional materials, clinical protocols, and clinical reports for products that are under his/her responsibilities.
10. Ensures compliance with regulatory requirements, including but not limited to change management, Chinese labeling requirements, etc.
11. Monitors regulatory and Standards developments affecting BD product he/she is responsible for, Identifies and recommends committees that BD should be part of.
DESIRABLE
B.S. or B.A. degree in a technical discipline (electrical engineering, bioengineering, chemical, biology, pharmaceutical preferred).
