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专业要求:

学历要求:不限

工作经验:不限

薪资待遇:8001-10000 月薪

招聘人数:1

招聘对象: 社会人才

我要投递简历

更新日期:2017-08-02

有效期:长期有效

年龄要求: 不限

外语要求: 不限

提供食宿:

工作地点: 上海

Job Purpose  Responsible for supporting the preliminary documentation for regulatory submissions concerning the CMC parts of CTA, NDA, license renewal and post approval change according to the agreed timelines. Major Activities
1.Provide high quality documentation and business support for development projects.Support the preparation of local specific documents according to the global CMC dossier. Support to the preparations of CMC change summary, risk assessment and other documents.Provide support to the HA lab testing if issues arise.Provide support to other RegCMC business as needed.2.Provide high quality and business support for marketed products.Perform preliminary gap assessment to support license renewalsReview variation dossier to support filing strategy for CMC changesAssist HA CMC query process as necessaryMonitor the variation tracking sheetIdeal Background 
Education :  (minimum/desirable):BS in Chemistry, Biology,   Pharmacy,   Biochemistry.
Languages:            Fluent English and Chinese  Experience/Professional requirement:          1.3-5 years in RA/CMC preferred, and/or  technical experiences in   manufacturing / testing of chemical drug/biopharmaceuticals2.Good written/spoken communication and problem solving skills.3.Computer literacy.Jobsite: Zhangjiang Shanghai    
  


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