Regulatory Affairs Executive

About the role

The Regulatory Affairs Executive ensures that all product licences remain valid and compliant with relevant laws and regulations across pharmaceuticals, medical devices, cosmetics and food products. Acting as the primary liaison with health authorities, the role supports the full product lifecycle from registration to post‑market activities.

Key responsibilities

• Serve as the full‑time liaison with FDA drug, food, medical device and cosmetics sections for new registrations, renewals, variations, notifications, one‑time permits, DIAC attachments, sticker and advertisement applications.
• Monitor regulatory changes, update internal procedures, and translate documents when required.
• Daily follow‑up with the health authority (HA) via online portals, report status to the Regulatory Manager, and prepare weekly/monthly submission reports.
• Verify product classifications with the HA and respond accordingly.
• Prepare and review registration, variation and notification dossiers, communicate client requirements, and submit dossiers in a timely manner.
• Coordinate FDA sample shipments, manage courier communications, handle sample receipt, and ensure readiness for submission.

Required profile

• Bachelor’s degree in Pharmacy.
• Strong command of English, both oral and written.
• Ability to follow the company’s Code of Conduct and comply with internal policies.
• Demonstrated capability to lead and develop staff and to contribute effectively to the executive management team.

Required skills

What we offer

• Opportunity to work with a leading healthcare solutions company operating in 17 Asian markets.
• Exposure to a wide range of regulated products and interaction with major health authorities.
• Professional development in a multinational environment.