Regulatory Specialist (Pharma)

About the role

We are looking for a detail‑oriented Regulatory Specialist to ensure our pharmaceutical products meet all local regulatory requirements and internal 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

• Maintain and provide all company and product documentation required for FDA inspections and requests.
• Manage trademark (TM) registrations and keep them up‑to‑date in the IPO system.
• Maintain the EDPS Certificate and submit quality reports to the DOH on schedule.
• Prepare and submit monthly regulatory reports as needed.
• Safeguard retention samples, COAs, and logbooks required by the FDA and coordinate local assay testing for commercial products.

Required profile

• Bachelor’s degree in Pharmacy.
• Licensed Pharmacist preferred (optional based on experience).
• Minimum 5 years of experience as a pharmacist in a pharmaceutical company handling drug products.
• Knowledge of FDA inspections, company and product documentation, and trademark processes.
• Experience with FDA submissions and Quality Assurance is an advantage.
• Strong documentation and report‑writing abilities.

Required skills

• FDA inspection procedures
• Trademark registration management
• Quality Assurance documentation
• Regulatory reporting

What we offer

• Opportunity to work with a dynamic regulatory team.
• Exposure to local and international regulatory agencies.
• Professional growth in the pharmaceutical sector.