Job Title
Regulatory Affairs Specialist Commercial & Medical Devices
Location
Bangkok, Thailand
(Hybrid onsite 2 days per week)
Job Purpose
The Regulatory Affairs Specialist is responsible for supporting regulatory activities related to commercial materials, medical devices, and ad-hoc regulatory projects. The role ensures compliance with local regulatory requirements, particularly Thai FDA regulations, and provides regulatory guidance to cross-functional stakeholders to support business continuity and compliance.
Accountabilities
Commercial Materials & Advertising Compliance
- Serve as the primary point of contact for periodic meetings with Global Advertising teams
- Review, create, and revise local SOPs related to commercial material handling
- Deliver training to new joiners and conduct refresher training on material handling SOPs
- Coordinate with Compliance teams for commercial material monitoring
- Partner with Legal teams for disclaimer revisions and related training
- Act as the Regulatory Affairs reviewer for commercial and promotional materials
- Provide regulatory consultation to ensure compliance of materials with local requirements
- Manage regulatory activities related to international symposiums held in Thailand
Medical Devices Regulatory Affairs
- Manage medical device company license renewal and revisions
- Act as a regulatory consultant on medical device regulatory requirements
- Support regulatory activities related to new medical devices and lifecycle management
Ad-hoc & Business-Critical Regulatory Support
- Support urgent drug variations impacting continuous supply
- Provide regulatory support for ad-hoc, high-priority projects as required
Education, Skills, and Experience
Education
- Bachelor's degree in a scientific discipline
Experience
- Minimum 3 years of Regulatory Affairs experience in drugs and medical devices
- Hands-on experience with Thai FDA liaison and regulatory submissions
- Experience in advertising and promotional regulatory compliance is preferred
Skills & Competencies
- Strong written and verbal communication skills in Thai and English
- Strong planning, organizational, and prioritization skills
- Excellent interpersonal skills with proven ability to collaborate cross-functionally
- Ability to work independently while contributing effectively in a team environment
Working Conditions
- Hybrid work model with 2 days onsite per week
