Responsibilities
Assist the RA team on registration documents preparation, translation and checking according to Chinese regulation.
Help to archive registration documents including paper & electronic documents to keep a good filing system.
Organize and put in order paper documents in RA storage room by setting up rules to name, print and label folder with the requirement of RA document management guide
Cooperate with RA colleagues to improve document management guide
Finish other assigned tasks by the department.
Qualification Required
Master·s degree and above in a biology or relevant scientific background.
Knowledge of ICH Guidelines, local regulations and GXPs is preferred
Be familiar with registration dossier.
Good learning, analytical and issue identification abilities, and attention to detail
Creative problem solver and keen ability to address current and anticipated issues
Good computer skill in EXCEL and WORD
Good level of English language (spoken /written)
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