1. Develop and implement registration plan for new products in oversea markets within relevant therapeutic areas.

2. Independently prepare registration documents for submission, ensure the quality, accuracy and format of regulatory submissions and other documentation comply with applicable laws, regulations, and company standards.

3. Manage registration submissions for new products registration and clinical trial applications.

4. Manage registration submissions for license renewal and variations of marketed products and ensure optimal regulatory support to product lifecycle management for business objectives.

5. Ensure successful implementation of Regulatory Affairs and high quality of filing dossier.

6. Establish and maintain direct contact with oversea market regulatory team for information sharing and ensuring timely support.

7. Support oversea market regulatory team to undertake interactions and negotiations with Regulatory Authorities to optimize regulatory approvals.

8. Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines. Closely follow up regulation changes and analyze/predict its impact on company registration strategies.

9. Keep international business lead informed for the progress of regulatory projects, identify and discuss critical issues and potential solutions before implementation.

10. Contribute to company systems development, support to develop or enhance regulatory related SOPs, management systems, working procedures, etc.

11. Documentations legalization arrangement.

Background and qualifications:

1. Bachelor’s degree in pharmaceuticals or other related field, or equivalent work experience

2. 2 years of experience or above in RA

3. Knowledge of worldwide drug development and regulatory process, expertise of international regulatory guidelines.

4. Understanding of market access needs and implementation of appropriate measures for health care purposes.

5. Strong interpersonal skills and ability to interface effectively with company local relevant functions and oversea market regulatory team.

上班地址：北京市