Regulatory Affairs Specialist

Cook Medical · Pathum Wan, Bangkok, Thailand

Location

Pathum Wan

Job Type

Full Time

Posted

June 21, 2026

Job Description

Overview
The Regulatory Affairs Specialist is responsible for planning and executing all activities necessary for product registration and maintenance of product license, including change management and maintain good communication with all Cook manufacturing facilities and entities to obtain support wherever required.
 Responsibilities 
Write and review new product and change submission dossiers for Cook Medical's products in Thailand in accordance with authority and company requirements.
Preparation and submission of additional licenses with Thai FDA such as License per Import and Special Access License.
Negotiate with local authorities on behalf of Company objectives. Act as the key person to communicate and negotiate with local regulatory authorities.
Understand and maintain database and systems used for regulatory controls and submission work.
Create and maintain training materials to improve aware...
        

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