Job Description
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.
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