2.Project follow-up and data collection: Responsible for collection of the required technical dossiers from India team for new filing, renewal filing, variation filing, and responses to CDE query, etc.

3.Translation: Responsible for translation (English to Chinese) of received documents for various submission.

4.Documentation and submission: Compile application dossiers as per China regulations & guidance, and complete the submission as per timeline. 5.Necessary activities after initial submission: To follow up the progress of various filings and carry out necessary activities including coastal testing, answer the questions from agency timely, arrange discussion/assessment on the deficiency letter, prepare the query response for submission till final approval obtained.
6.Regulatory insight: Responsible for sharing and communication with India RA team about updated NMPA/CDE/CFDI etc. regulations and guidelines. 7.Communication with authorities: Responsible for communication with the authorities including but not limit to NMPA, CDE, NIFDC, port IDC, etc., so as to smooth the registration/coastal testing progress.

8.Others: Finish the other RA related work and BD supports sometimes for the Product and regulatory research as per assignment.

任职要求：

1. 本科或本科以上药学相关专业毕业；具有良好的英语阅读和写作能力以及比较流利的口语。

2. 具有药品注册申报资料的实际翻译（英译中），整理和申报递交经验；

3. 具有2年或2年以上药品注册申报相关工作经验，尤其具有进口仿制药（制剂或原料药）的申报注册和再注册经验予以优先考虑；

4. 熟悉《药品注册管理办法》及药品注册相关的最新法规与指南，熟悉进口/国产药品注册申报与注册检验流程；

5. 具有与药品注册相关各法规部门沟通的能力，包括但不限于国家局，省局，药审中心，口岸药检所等；

6. 具有药品注册信息检索和分析调研能力；