RA PM - Post Approval

1. Schedule strategies and timeline for post-approval variation filings and IDL renewal filings etc. based on the regulatory & commercial requirements.

2. Communication with NMPA or CDE etc. to ensure the variation approval based on timeline.

3. Regular operations for post-approval Supporting activities, such as adverse events, PSUR reports submission, complaints from partners in China.

Requirements:

1. Bachelor or Master Degree in pharmacy or related discipline.

2. Self-driven, detail oriented and responsible with good communication skills.

3. Good at English writing, reading.

4. At least 5-7 years of RA working experience and more than 3 years in post-approval regulatory affairs of imported drugs.

5. Excellent problem solving & decision making skills, can work with high level of accuracy.

6. Candidates with similar regulatory experience in MNC will be considered on priority.