I am a dedicated regulatory affairs professional transitioning into freelance data labeling and annotation. With 15 years of experience ensuring regulatory compliance for healthcare products in Thailand, I bring meticulous attention to detail, strong organizational skills, and a consistent, quality-focused approach that translates well to data labeling tasks. Throughout my career, I led regulatory strategies, managed complex dossiers, and collaborated across R&D, manufacturing, and commercial teams to align with global and local requirements. I’m excited to apply my process-driven mindset, risk assessment, and documentation discipline to high-quality data labeling projects.

Karagate Kominta

I am a dedicated regulatory affairs professional transitioning into freelance data labeling and annotation. With 15 years of experience ensuring regulatory compliance for healthcare products in Thailand, I bring meticulous attention to detail, strong organizational skills, and a consistent, quality-focused approach that translates well to data labeling tasks. Throughout my career, I led regulatory strategies, managed complex dossiers, and collaborated across R&D, manufacturing, and commercial teams to align with global and local requirements. I’m excited to apply my process-driven mindset, risk assessment, and documentation discipline to high-quality data labeling projects.

Available to hire

I am a dedicated regulatory affairs professional transitioning into freelance data labeling and annotation. With 15 years of experience ensuring regulatory compliance for healthcare products in Thailand, I bring meticulous attention to detail, strong organizational skills, and a consistent, quality-focused approach that translates well to data labeling tasks.

Throughout my career, I led regulatory strategies, managed complex dossiers, and collaborated across R&D, manufacturing, and commercial teams to align with global and local requirements. I’m excited to apply my process-driven mindset, risk assessment, and documentation discipline to high-quality data labeling projects.

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Language

Thai
Fluent
English
Advanced

Work Experience

Regulatory Affairs Consultant at Smart Reg-MedPharma (Thailand) Ltd.
March 1, 2025 - November 6, 2025
Providing strategic guidance to ensure compliance with Thai regulations for healthcare products. This includes assisting with product registration, post-approval submissions, and ongoing lifecycle maintenance.
Regulatory Affairs Manager at Galderma (Thailand) Ltd.
July 1, 2024 - February 28, 2025
Developing regulatory strategies for pharmaceuticals, medical devices, and cosmetics. This involves planning and managing regulatory filings, creating and implementing regulatory strategies, and participating in global and regional meetings to align Thai filing plans. Additionally, responsibilities include maintaining licenses, advising stakeholders, and overseeing labeling, package inserts, and the review of promotional materials.
Regulatory Affairs Manager at Bausch & Lomb (Thailand) Ltd.
May 1, 2017 - June 30, 2024
Handling registrations and amendments for healthcare products; artwork management for product launches and labeling updates; cross-functional coordination; conducting assessments of project-related changes; managing quality processes, including product redressing, re-labelling, and evaluating and reporting complaints to ensure the highest standards are met.
Assistant RA and QA Manager at Abbott Laboratories Ltd., Thailand
May 2, 2016 - April 28, 2017
Managing product registrations and amendments, supporting product launches to ensure regulatory compliance, guiding marketing teams, and reviewing technical and quality documents.
Regulatory Pharmacist at Johnson&Johnson (Thailand) Ltd.
August 1, 2014 - April 29, 2016
Performing product registration and labeling assessments to ensure regulatory compliance with both local and global requirements, and contributing regulatory expertise to project teams.
Regulatory Pharmacist (Study Start-up) at Ecron Acunova Company Ltd., Thailand
November 1, 2011 - July 31, 2014
Preparing submission packages to ensure compliance with FDA, Ethics Committee requirements; maintaining essential documents; reviewing labeling and patient information forms; and providing regulatory support to sponsors and project teams.
Regulatory Pharmacist at BIC Chemical Co., Ltd., Thailand
July 1, 2009 - July 30, 2010
Compiling registration dossiers for regulatory submissions, following up with authorities to obtain approvals, maintaining registration files, and ensuring ongoing regulatory compliance.
Research and Development Pharmacist at Pond’s Chemical Thailand R.O.P
March 1, 2005 - November 28, 2008
Leading the development of robust formulations, supporting the development of analytical methods and production transfers, and preparing documentation and labeling for medicine registrations.

Education

MSc Drug Development at University of Aberdeen, UK
September 1, 2010 - August 31, 2011
B.Pharm at Chiang Mai University, Thailand
May 1, 2000 - February 28, 2005

Qualifications

Add your qualifications or awards here.

Industry Experience

Healthcare, Life Sciences, Professional Services, Manufacturing, Wholesale & Distribution