Regulatory Affairs Specialist – Asia Pacific

About the role

TRB Chemedica Malaysia is seeking a Regulatory Affairs Specialist to support its product portfolio across the Asia Pacific region. The role focuses on managing product registrations, ensuring regulatory compliance, and coordinating technical documentation for both pharmaceuticals and medical devices with regional health authorities.

Key responsibilities

• Prepare and submit product registration dossiers for pharmaceuticals and medical devices to health authorities in APAC markets.
• Maintain ongoing compliance with regional regulatory requirements and updates.
• Coordinate the collection, review, and submission of technical documentation required for regulatory approvals.
• Liaise with internal teams and external agencies to ensure timely and accurate regulatory submissions.

Required profile

• Experience in regulatory affairs related to pharmaceuticals or medical devices.
• Familiarity with APAC regulatory frameworks and submission processes.

Required skills

What we offer

• Opportunity to work within a multinational company established in APAC since the early 1980s.
• On‑site work environment in Kuala Lumpur.