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

Regulatory Affairs Specialist

Regulatory Affairs Manager