Regulatory Affairs Specialist
Freyr Solutions
Posted
last week
Bangkok, Thailand
Remote
THB 60K
Mid Level
Full Time
Sema Summary
The Regulatory Affairs Specialist ensures compliance with local Thai FDA regulations and provides guidance to stakeholders. The role involves supporting regulatory activities related to commercial materials and medical devices.
About Company
Freyr Solutions is a global leader in Regulatory solutions for life sciences industries, providing comprehensive services to navigate the complex Regulatory landscape.
Core Requirements
- Bachelor's degree in a scientific discipline
- Minimum 3 years in Regulatory Affairs
- Experience with Thai FDA liaison
- Hands-on experience with regulatory submissions
- Strong communication skills in Thai and English
Responsibilities
- Serve as a primary contact for Global Advertising teams
- Review and create local SOPs for material handling
- Deliver training on material handling SOPs
- Coordinate with Compliance teams for monitoring
- Act as a Regulatory Affairs reviewer for promotional materials
- Manage medical device company license renewals
- Support urgent drug variations impacting supply
Must Have skills
Job Keywords
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