Regulatory Pharmacist

Job description:

The Regulatory Pharmacist is responsible for the following:

• Oversee and ensure compliance with all Philippine FDA regulations for food supplements, pharmaceuticals and manufacturing practices.
• Maintain and renew the facility's License to Operate (LTO) and Good Manufacturing Practice (GMP) certifications.
• Manage the process for Certificate of Product Registration (CPR) for new and existing products.
• Prepare and submit all necessary documentation for product registrations, renewals, and regulatory submissions in accordance with local regulations.
• Acts as technical point person on regulatory concerns, guidelines and procedures pertaining to cosmetics, pharmaceutical, food, etc., issued and carried out by FDA, DENR, Tarif Commission, etc. Implement and monitor regulatory strategies to comply with local regulatory requirements.
• Coordinate with the technical committees, making sure that SOP’s and regulatory guidelines are being followed and implemented and executed accordingly.
• Attend seminar (CCIP/FDA seminars and other seminar related to business) as necessary to be updated on the latest rules, regulations and practice.

Job requirements:

• Licensed Pharmacist with a valid PRC License
• With or without experience in Regulatory Affairs, preferably in the pharmaceutical, medical device, cosmetics, or food industry.
• Knowledge of Philippine FDA regulations and product registration processes.
• Strong attention to detail, organization, and documentation skills.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Office applications.
• Able to work independently and manage multiple regulatory deadlines.

The selected applicant will be assigned to one of our affiliated companies specializing in the distribution of medical devices.