* Prepare & submit documents, deliver timetable for license granted. 负责产品注册包括资料准备、整理、递交等，并在规定的时间内完成；
* Responsible for license maintenance/DMF including renewal, variation, PI, label etc. 负责产品注册证维护工作，包括再注册，变更，说明书及标签等工作；
* Responsible for regulatory collection, analysis and implementation. 负责法规的收集、分析和实施；
* Support site audit. 为现场核查提供支持；
* Responsible for variation assessment from plant (leverage Trackwise 8 when possible). 提供和工厂注册相关的变更评估和信息；
* Support other departments such as bidding, market, PV etc. 支持相关部门工作如招标、市场、药物警戒等部门；
* Responsible for archiving registration dossiers(leverage BaxEdge or sharepoint) . 负责注册文件归档；
* Responsible for other tasks assigned by supervisor above and support GRA CMC related tasks. 负责完成主管的工作任务安排；
* Develop and improve good relationship with the authorities and promote Baxter image. 与法规相关政府机构保持良好沟通。

其他信息

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