Napatthra Udompongpipat
Regulatory Affairs
Meuang
Summary
Self-motivated Regulatory Affairs holding 6 years of Regulatory Affairs experience. Excellent project management abilities, including facilitation, organization and time management.
Overview
7
7
years of professional experience
2
2
Languages
Work History
Regulatory Affairs Associate
Lotus Pharmaceutical (Thailand) Co., Ltd.
01.2024 - Current
- Registered new generic drug products and responded to regulatory queries.
- Maintained and updated regulatory dossiers, GMP clearances, and import licenses, (including company license change projects.)
- Review drug annual reports and oncology drug reports before submitting.
- Provided regulatory documentation support for the Commercial team.
- Acted as Local Pharmacovigilance Officer, responsible for pharmacovigilance activities and reporting adverse events (AEs) to the regulatory authority.
- Reviewed Certificates of Analysis (COA) and coordinated product release activities to ensure seamless market availability.
- Kept up-to-date with changes in regulatory legislation and guidelines and obtained marketing permissions.
Regulatory affairs executives
Paradigm Pharma (Thailand) Co., Ltd.
04.2022 - 12.2023
- Prepared and submitted baseline and variation applications via e-submission systems.
- Prepared, submitted, and monitored product registration, renewal, variations, and GMP clearances across ASEAN countries, including Myanmar, Cambodia, the Philippines, and Vietnam.
- Prepared Standard Operating Procedures (SOPs) and related forms for Good Distribution Practice (GDP) certification submissions.
- Prepared and submitted promotional materials for advertisement approval in compliance with regulatory requirements.
- Prepared regulatory documentation to support hospital product enlistment.
Quality Control Pharmacist
M & H Manufacturing Co., Ltd
04.2021 - 04.2022
- Managed testing and documentation for finished products, raw materials, stability studies, and validation activities.
- Prepared supporting documents for variation applications, including analytical procedures, Certificates of Analysis (COA), and specifications.
- Prepared documentation and procured reagents, reference standards, and laboratory glassware for implementation of new analytical methods.
- Managed the preparation and availability of primary standards, secondary standards, and working standards.
Regulatory Affairs Pharmacist
L.B.S. Laboratory Ltd., part
07.2019 - 03.2021
- Completed all required documentation for variation applications to amend commercial products.
- Prepared regulatory documentation for new product registration submissions.
- Managed license renewal and variation submissions in compliance with regulatory requirements.
- Responded to customer inquiries and provided accurate product information.
Education
Faculty of Pharmacy - Pharmaceutical Science, Pharmaceutical biology
Silpakorn University
01.2019
Skills
Interpersonal skill
Teamwork
Time management
Timeline
Regulatory Affairs Associate
Lotus Pharmaceutical (Thailand) Co., Ltd.
01.2024 - Current
Regulatory affairs executives
Paradigm Pharma (Thailand) Co., Ltd.
04.2022 - 12.2023
Quality Control Pharmacist
M & H Manufacturing Co., Ltd
04.2021 - 04.2022
Regulatory Affairs Pharmacist
L.B.S. Laboratory Ltd., part
07.2019 - 03.2021
Faculty of Pharmacy - Pharmaceutical Science, Pharmaceutical biology
Silpakorn University
LANGUAGES
Thai
Native or Bilingual
English
Professional Working
Training
Abbott Laboratories — Regulatory Affairs
Internship (3 months)
Government Pharmaceutical Organization–Merieux Biological Products Co., Ltd. — Regulatory Affairs & Quality Assurance
Internship (4.5 months)