Regulatory Pharmacist

About the role

The Regulatory Pharmacist will lead the company’s interactions with the FDA and other health authorities, ensuring that all pharmaceutical, medical device, food and cosmetic products meet regulatory standards. This role combines technical expertise with cross‑functional collaboration to support product launches, renewals and compliance activities.

Key responsibilities

• Prepare and submit LTO applications, renewals and variations.
• Manage product registration processes for drugs, medical devices, foods and cosmetics, including documentation preparation for FDA submission.
• Renew Certificates of Product Registration (CPRs) and monitor related deadlines.
• Coordinate CLIDP applications with distributors and handle amendment/variation submissions.
• Review and proof product labels for primary and secondary packaging to ensure FDA labeling compliance.
• Maintain proactive communication with the FDA to track application status.
• Update and audit Standard Operating Procedures (SOPs) in line with current regulations.
• Monitor the Electronic Drug Price Monitoring System (EDPMS) as required by the DOH.
• Oversee product‑related issues, including customer complaints, recalls, withdrawals and distribution returns.
• Manage IPO applications and maintain secure documentation for CPRs and LTOs.

Required profile

• Bachelor’s degree in Pharmacy or a related field.
• Licensed Pharmacist with at least 2‑3 years of relevant experience.
• 3‑5 years of regulatory affairs experience within the pharmaceutical industry.
• Strong understanding of FDA regulatory guidelines and product registration processes.
• Excellent communication, critical‑thinking and detail‑oriented work habits.
• Ability to work independently and collaboratively across functions.
• Willingness to travel occasionally.

Required skills

• FDA regulatory guidelines
• Product registration and submission
• Label compliance review
• Standard Operating Procedures (SOP) management
• Electronic Drug Price Monitoring System (EDPMS) monitoring