Job Description:

1. Coordinate with the regulatory team based in India and translate the DMF shared from Indian office in Chinese for submission as per the given timeline

2. Translate the amendment and annual reports that are shared by Indian office

3. Responsible for tracking of queries and letter of access issued to various customers

4. Coordinate and ensure the sample requirement from India to PIFDC as per the timelines and maintain the tracker for the samples shared with agency.

5. Follow up the open issues for the new submissions and ensure the closure with the Indian regulatory team

6. Follow up with relevant departments including production unit, QA, QC, medical department to deal with problems encountered during regulatory inspection

7. Write the CDs DVD’s of the Applicant’s Part DMF and courier it to customers

8. Take up the administrative activities such as courier of the Applicant’s Part DMF, Letter of access, original declaration to customers and agencies and to India office

9. Follow up with the business team for the payment of the fee to the agents and agency.

10. Prepare the necessary presentations required for the department and organization

11. Maintain good knowledge in general/product specific scientific and regulatory requirement/ process.

12. Maintain strong working relationship and communications with internal regulatory team to provide regulatory information.

13. Provide support to Policy & Intelligent management or Database development, update and maintenance.

Qualification Requirement:

1. University graduate; Pharmacy, Chemistry or related; Master in Pharmaceutical relevant subject preferred.

2. Working Experience:

3. Good regulatory knowledge and experiences in Chinese regulation

4. Minimum 5 years in the pharmaceutical industry.

5. Comprehensive understanding of China registration and compliance.

6. Workable English skills both in written and oral

7. Ability to handle multi-task activities

上班地址：古北Soho