Regulatory Affairs Specialist

Nộp hồ sơ ứng tuyển: Ứng viên ứng tuyển vui lòng nộp hồ sơ trên trang tuyển dụng Sysmex ở link sau: [protected info]
=> Các hồ sơ không nộp trên trang tuyển dụng của Sysmex sẽ không được xử lý.
Key Job Purpose:
• Dossier preparation & product registration submission to Vietnam Ministry of Health (MOH), leading to timely introduction of new products as well as Renewal/Change Notification.
• Provide regulatory support, update, advisory & knowledge sharing to other departments, distributors and Sysmex Asia Pacific in order to remain in compliance with the government regulatory requirements in Vietnam.
• Serve as the primary contact between the company and regulatory agency-MOH. Maintain and develop relationships with MOH and relevant organizations.
Summary of Functional Duties & Responsibilities:
1. Contact to Sysmex Asia Pacific regulatory affair department to get necessary documents for Sysmex Vietnam.
2. Prepare & submit product registration documentation & other relevant licenses' application and ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements that lead to timely approval of new product registration in Vietnam.
3. Notify and update MOH of any changes in particulars/documents related to product registration.
4. Ensure changes to the approved products are timely submitted to MOH as required.
5. Maintain product registration records and product registration databases to ensure proper documentation and record filing.
6. Act as a contact between the company and the MOH, maintaining and developing relationships with the MOH and relevant organizations.
7. Compile all relevant legal requirements from the departments; maintain and update master list of regulation requirement. Coordinate with the departments to assess compliance with the regulations.
8. Support other departments in all regulatory related areas, legal compliance matters if required.
9. Prepare and manage sub-labels according to regulation.
10. Manage translation of registration document as package insert, instruction for use, registration documents...
11. Read, update and follow company's standard operating procedures and guidelines in daily work.
12. Support Managers/Supervisor to make, review and improve standard operating procedures and guidelines.
13. Establish procedure/work instructions of RA department according to supervisor' instruction.
14. Participate in the company's regular audits.
15. As a company representative, working with legal consultants to advise/handle on the company's legal matters (legal contracts, business license, investment registration license...)
16. Join meeting & training according to Manager/ Supervisor's instructions.
17. Any other duties as may be assigned.