Job Description

Support regulatory affairs daily work

Responsibilities

Responsibility:

Ÿ   Assist RA Lead to research on overseas and local policy, regulation and technical guideline in field of Genetherapy and Cell therapy.

Ÿ   Schedule the relevant meetings/workshops and seminars, arrange the logistics and record the meeting minutes.

Ÿ   Assist RA lead to write and complete the final research report.

Ÿ   Commercial Intelligence searching and summary

Qualification Required

Ÿ   Bachelor degree and above in life sciences or relevant scientific background.

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

Ÿ   Be familiar with the 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 skills in EXCEL and WORD

Ÿ   Good level of English language (spoken /written)