Preview Resume

Expected Salary

44,000 - 46,500

Military Status

- Exempted

Job Requirment

Job Categories : Legal

Job Sub Categories : Legal Officer

Job Position : Senior Regulatory Affairs Officer

Job Categories : Legal

Job Sub Categories : Legal Officer

Job Position : Regulatory Affairs Specialist

Job Categories : Legal

Job Sub Categories : Legal Officer

Job Position : Regulatory Affairs Officer

Interested business type : Medicine / Cosmetic / Medical Equipment

Job Location : Bangkok (All)

Job Type : Full time

Availability : within 30 days

Working Bangkok : Yes

Willing to work oversea? : Yes

Education

King Mongkut's University of Technology Thonburi

Graduation year : 2015

Certificate : Bachelor's Degree

Faculty : Science

Major : Chemistry

GPA : 2.45

Work Experience/Trainee

2024

Business Type : Medicine / Cosmetic / Medical Equipment

Last Position : Regulatory Affairs Officer

Period : November 2024 to Present

Job Description :

1. Prepare and submit product registration dossiers to obtain regulatory approval for medical device registration.
2. Manage regulatory documentation, including creation, maintenance, and updating of product-related documents such as labeling to ensure compliance and accuracy.
3. Coordinate and communicate with regulatory authorities (e.g., FDA), external agencies, and internal departments (e.g., Sales, Product Specialists) to support registration activities and ensure accurate information flow.
4. Monitor submission progress and provide regular status updates to management and relevant stakeholders, including notification of regulatory or legislative changes.
5. Manage product license renewal and variation processes, ensuring timely renewal of expired registrations and updates in accordance with applicable regulations.
6. Liaise with overseas manufacturers and relevant stakeholders to support regulatory submissions and compliance requirements.
7. Prepare and submit applications for medical device advertising licenses in compliance with regulatory requirements.
8. Prepare Import License (LPI) documentation and coordinate factory inspections for Thai Industrial Standards (TIS) certification with the Thai Industrial Standards Institute (TISI).
9. Prepare documentation for customs tariff classification requests to support import and regulatory compliance processes.
10. Perform other regulatory affairs-related duties as assigned.

2022

Business Type : Medicine / Cosmetic / Medical Equipment

Last Position : Regulatory Affairs

Period : March 2022 to July 2024

Job Description :

1. Prepare regulatory documentation and classification checklists, including risk classification of medical devices (Non-IVD and IVD) for product registration submissions.
2. Liaise and coordinate with the Food and Drug Administration (FDA) to obtain required licenses and approvals.
3. Prepare and submit documentation for Importer Establishment Licenses, including renewal applications for medical device import licenses.
4. Maintain, update, and ensure validity of import-related licenses, including proper document control and availability for regulatory use at all times.
5. Monitor and communicate updates on medical device regulations to relevant stakeholders within the organization.
6. Prepare annual import and sales reports for medical devices in compliance with regulatory requirements.
7. Prepare documentation for product testing requests and coordinate factory inspections for Thai Industrial Standards (TIS) certification with the Thai Industrial Standards Institute (TISI).
8. Prepare documentation for customs tariff classification requests to support import processes.
9. Perform other regulatory affairs-related duties as assigned.

2017

Business Type : Medicine / Cosmetic / Medical Equipment

Last Position : Regulatory Affairs

Period : July 2017 to March 2022

Job Description :

1. Prepare regulatory checklists and review documentation for medical device registration submissions and drug registration applications.
2. Submit applications for variations and amendments to existing licenses, as well as handle renewals of import licenses for pharmaceuticals and medical devices.
3. Prepare and submit applications for establishment licenses for importation of modern medicines, traditional medicines, and medical devices.
4. Monitor and communicate updates on pharmaceutical and medical device regulations to relevant stakeholders within the organization.
5. Prepare annual import reports for pharmaceuticals and medical devices in compliance with regulatory requirements.
6. Liaise and coordinate with analytical laboratories and the Food and Drug Administration (FDA) to support regulatory submissions and compliance activities.
7. Prepare Import License (LPI) documentation for pharmaceuticals and medical devices.