Regulatory Specialist

About the role

We are looking for a detail‑oriented and proactive Regulatory Specialist to ensure our pharmaceutical products meet all local regulatory requirements and company standards. You will collaborate with cross‑functional teams, external partners, and regulatory agencies such as the IPO, DOH, local laboratories and the FDA.

Key responsibilities

• Assist the Regulatory Department by keeping all company and product documents ready for FDA inspections and requests.
• Maintain trademark (TM) registrations and ensure they are up‑to‑date in the IPO system.
• Manage the EDPS Certificate and submit timely quality reports to the DOH.
• Prepare and submit required monthly reports.
• Safeguard retention samples, COAs and logbooks required by the FDA and coordinate local assays for commercial products.

Required profile

• Bachelor’s degree in Pharmacy.
• Minimum 5 years experience as a pharmacist within the pharmaceutical industry handling drug products.
• Knowledge of FDA inspection processes, company and product documentation, and trademark maintenance.
• Experience with FDA submissions and Quality Assurance is an advantage.

Required skills

• FDA inspection knowledge.
• FDA submission experience.
• Quality Assurance practices.
• Trademark registration and maintenance.
• EDPS Certificate management.