Responsibilities

Ÿ   Assist the RA team on registration documents preparation, translation and checking according to Chinese regulation.

Ÿ   Help to archive registration documents including paper & electronic documents to keep a good filing system.

Ÿ   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

Ÿ   Cooperate with RA colleagues to improve document management guide

Ÿ   Finish other assigned tasks by the department.

Qualification Required

Ÿ   Master·s degree and above in a biology or relevant scientific background.

Ÿ   Knowledge of ICH Guidelines, local regulations and GXPs is preferred

Ÿ   Be familiar with registration dossier.

Ÿ   Good learning, analytical and issue identification abilities, and attention to detail

Ÿ   Creative problem solver and keen ability to address current and anticipated issues

Ÿ   Good computer skill in EXCEL and WORD

Ÿ   Good level of English language (spoken /written)