Regulatory Pharmacist

Main Source Manufacturing and Trading Corp.; Caloocan; On-site; PHP 300,000 - 600,000; Full time

Job summary

A manufacturing company located in Metro Manila, Caloocan, is seeking a professional to act as a liaison with regulatory agencies, ensure compliance with Good Manufacturing Practices, and manage documentation control. The ideal candidate will have experience in regulatory compliance and strong organizational skills. This role is crucial in maintaining manufacturing standards and ensuring product safety.

Qualifications

• Experience with regulatory compliance and Good Manufacturing Practices.
• Ability to coordinate with multiple regulatory agencies.
• Strong organizational and documentation skills.
• Detail-oriented with strong documentation control practices.

Responsibilities

• Acts as a liaison with government and regulatory agencies.
• Guides compliance with Good Manufacturing Practices.
• Ensures documentation control of regulatory documents.
• Trains employees on Good Manufacturing Practices.
• Maintains a hazard-free working environment.
• Coordinates with agencies regarding applications and concerns.
• Prepares requirements for permits, licenses, and registrations.
• Discusses completion of requirements for permits and registrations with Plant Manager.
• Trains employees on GMP modules.
• Writes Standard Operating Procedures related to GMP.
• Oversees documentation control on regulatory and manufacturing files.
• Performs quality control and QA tasks as needed.
• Acts as the authorized person for release of finished products.
• Maintains a hazard-free working environment.

Skills

Regulatory liaison

GMP compliance

Documentation control

Regulatory reporting

Job description

• Acts as a liaison of the company and transacts with relevant government and regulatory agencies, including but not limited to the Food and Drug Administration, Bureau of Animal Industry, and Department of Trade and Industry.
• Keeps the company updated with significant issuances and requirements from different agencies.
• Guides the company in complying with Good Manufacturing Practices (GMP) and checks their implementation at work.
• Ensures the documentation control of regulatory and manufacturing documents.
• Ensures the validity of permits, licenses, and product registrations.
• Updates the company with significant issuances from regulatory agencies.
• Coordinates with regulatory agencies regarding applications and other concerns.
• Prepares the requirements for applications for permits, licenses, and product registrations.
• Discusses the completion of requirements (e.g., third‑party analysis, studies, etc.) for applications of permits, licenses, and product registrations with the Plant Manager.
• Ensures that Good Manufacturing Practices are being followed during work.
• Trains company employees on the different modules of Good Manufacturing Practices.
• Coordinates plans for improvement on GMP‑related matters and documentation control with the Plant Manager.
• Oversees documentation control on regulatory and manufacturing‑related files.
• Writes Standard Operating Procedures relevant to Good Manufacturing Practices.
• Keeps documents up to date and relevant.
• Summarizes the forms being used in the manufacturing plant.
• Revises forms whenever changes are necessary.
• Performs and assists in quality control and quality assurance tasks when deemed necessary.
• Acts as the authorized person for the release of finished products.
• Maintains a hazard‑free working environment.
• Performs other duties as may arise from time to time and as may be assigned to the employee.