Regulatory Affairs Officer (Invitro Diagnostics) 9 Months Temporary contract

Please note: 9 months temporary contract
Key Job Purpose:
• Dossier preparation & product registration submission to Vietnam Ministry of Health (MOH), leading to timely introduction of renewal as well as new products and responsible for supplemental filings for any changes.
Summary of Functional Duties & Responsibilities:
1. 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.
2. Notify and update MOH of any change of particulars/documents related to product registration.
3. Ensure changes to the approved products are timely submitted to MOH as required.
4. Maintain product registration record and product registration database to ensure proper documentation and record filing.
5. Maintain the knowledge and awareness of current applicable regulations and standards.
6. Manage sub-label and PI and the redressing instructions.
7. Read, update and follow company's standard operating procedures and guidelines in daily work.
8. Support other departments in all regulatory and tender related areas.
9. Support tasks for translation request.
10. Prepare Material Safety Data Sheet according to regulation.
11. Any other duties as may be assigned.
Authorize :
• To use of equipment and facilities of the Company to serve the purpose to complete the task.
• To enjoy the full benefits stipulated in the labor contract, labor agreement and labor law.
• To refuse to perform the tasks assigned by Manager/ Superiors which not in conformity with the law.

Attractive Salary
,#Allowance of: Transportation
,#Professional, dynamic and friendly working environment

Technical Service, Customer Satisfaction, Application Development, Customer Orientation, Medical Research