Regulatory Affairs Officer

Job Title                                         REGULATORY AFFAIRS OFFICER

Country                                          Vietnam, Hanoi

Position Type                                 Limited contract (6 months)

Immediate Superior (title)              RA Team Leader

Immediate Subordinates (title)      None

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. Follow up the status of registration documents with MoH to obtain the license on time.
4. Ensure changes to the approved products are timely submitted to MOH as required.
5. Maintain product registration record and product registration database to ensure proper documentation and record filing.
6. Maintain the knowledge and awareness of current applicable regulations and standards.
7. Manage sub-label and PI/IFU.
8. Read, update and follow company's standard operating procedures and guidelines in daily work.
9. Support Managers / Supervisors to make, review and improve standard operating procedures and guidelines.
10. Support other departments in all regulatory and tender related areas.
11. Support tasks for translation request.
12. Any other duties as may be assigned.

Authorize :

• To use 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.
• To co-operate with relevant departments to carry out daily works under the provisions of the Company.

Job Specification :

Minimum Education Required

Degree in Medical science or equivalent

Minimum Experience Required

Min 6 months relevant working experience

Skills and Knowledge Required

PC literate, Good English in Speaking, Reading, Translation, Good communication.

Attitude Required

Hardworking and careful, positive mindset of customer satisfaction, teamwork and compliance

Knowledge Desired but not Essential

Biomedical or Healthcare

Travel Requirement

Flexible to respond to company request for company, regional training/meeting

Key Competencies :

Good

V. Good

Excellent

1.

Plans and Organizes Effectively

x

2.

Produce Quality Work-Meticulous & meet deadline

x

3.

Reliability

x

4.

Effective time management

x

5.

Communicates effectively

x

6.

Positive learning attitude & quick learner

x

7.

Analytical ability and coves problems

x

8.

Collaborates with others and teamwork

x

9.

Customer focused

x

10.

Project management

x