该职位来源于猎聘 Responsibilities:
- Schedule strategies and timeline for post-approval variation filings and IDL renewal filings etc. based on the regulatory & commercial requirements.
- Communication with NMPA or CDE etc. to ensure the variation approval based on timeline.
- Regular operations for post-approval Supporting activities, such as adverse events, PSUR reports submission, complaints from partners in China. Requirements:
- Bachelor or Master Degree in pharmacy or related discipline.
- Self-driven, detail oriented and responsible with good communication skills.
- Good at English writing, reading.
- At least 5-7 years of RA working experience and more than 3 years in post-approval regulatory affairs of imported drugs.
- Excellent problem solving & decision making skills, can work with high level of accuracy.
- Candidates with similar regulatory experience in MNC will be considered on priority.