Responsibilities :
1.Handle all regulatory affairs works in the responsible therapeutical areas and to ensure them match the registration timeline.
2.Ensure all translating and compiling dossiers are correct and in compliance with Chinese regulation and effectively summarize professional report in verbal and written for drug registration.
3.Solve the problem arise from the product registration procedure to get the approvals timely in uncertainly regulatory environment within China.
4.Coordinate with Manufacture Site and Regulatory Affairs Department.
5.Provide regulatory support to the other departments or teams in explaining Chinese regulation to InRA and give input as their requirements.
Qualifications:
1. A bachelor degree in pharmacy, medical or related background,
2. Over 2 years' regulatory affairs working experience in pharmaceutical company.
3. Proven ability to communicate (written/verbal) in English