Responsibilities: 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.