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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.

任職要求：

1. 本科或本科以上藥學相關專業畢業；具有良好的英語閱讀和寫作能力以及比較流利的口語。

2. 具有藥品注冊申報資料的實際翻譯（英譯中），整理和申報遞交經驗；

3. 具有2年或2年以上藥品注冊申報相關工作經驗，尤其具有進口仿制藥（制劑或原料藥）的申報注冊和再注冊經驗予以優先考慮；

4. 熟悉《藥品注冊管理辦法》及藥品注冊相關的最新法規與指南，熟悉進口/國產藥品注冊申報與注冊檢驗流程；

5. 具有與藥品注冊相關各法規部門溝通的能力，包括但不限于國家局，省局，藥審中心，口岸藥檢所等；

6. 具有藥品注冊信息檢索和分析調研能力；