Responsibilities：

1、Provide QC review for registration dossiers (including IND, NDA, renewal, supplementary application, annual report, Briefing Documents for CDE consultation meeting, etc) within specified time limit in accordance with RA SOPs and relevant regulations and feed back QC opinions to project managers. Sign the Check and Approval Form of Registration Dossiers if the QC results meet the requirements.

2、Archive administrative documents and SOPs and propose for their update as necessary.

3、Assist in the preparation, review, submission, tracking and approval of IND and NDA dossiers and help solve problems arising in the registration process.

4、Assist in organizing the training for administrative docuents and SOPs of RA department and providing orientation training for new staff and keep the training records.

5、Perform other duties assigned by line manager.

Qualifications：

1、Bachelor degree or above in Pharmacy, Medicine, Chemistry, Biology or related disciplines.

2、2+ years of working experiences in pharmaceutical industry.

3、Good English reading and writing skills.

4、Good communication and expression skills; Knowledge and practice in registration regulations and procedures; Details orientation.

5、Good computer skills.