Position Overview
Our client is a leading medical device manufacturer in Thailand.
Key Responsibilities
Assisting in regulatory issues including product registration submission, variation application, and advertising company licenses following Thai Regulations.Interacting and coordinating with regulatory agencies to expedite the approval of registrations.Assisting in reviewing regulatory documents and materials such as package inserts, labels, and other packages.Supporting other regulatory issues such as COA translation, goods release, SOPs, etc.Maintaining regulatory database and reporting regularly.Supporting Regulatory Affairs Leader and regulatory team in preparing purchase requests, and expenditures, supporting internal communication work, meetings, sending sample testing, etc.Preparing documents for batch release application, sample license, raw material permission, and variation packaging per timeline, to submit at Thai...