Regulatory Affairs Assistant

Belman Laboratories; Mandaluyong; On-site; PHP 300,000 - 600,000; Full time

Job summary

Belman Laboratories is seeking a regulatory affairs professional to assist in preparing and submitting licenses, registrations, and permits with FDA, BAI, and DENR in the Philippines.

The role involves coordinating with government agencies, maintaining compliant records, and staying updated on regulatory guidelines through seminars and training. A strong attention to detail and liaison skills are essential for ensuring timely approvals.

Responsibilities

• Assist in preparing and compiling applications for Licenses to Operate, Certificate of Product Registration, Certificates of Good Manufacturing Practice, and Feed Product Registration with FDA and BAI.
• Support the documentation and submission of Laboratory Recognition Certificates, Wastewater Discharge Permits to Operate, and Trademark Registration.
• Coordinate timely submission of reports to DENR such as the Self-Monitoring Report (SMR) and Compliance Monitoring Report (CMR).
• Help track expiration dates of all company permits and assist in renewal document preparation.
• Coordinate with regulatory bodies (FDA, BAI, DENR, IPOPHIL) for updates and compliance requirements.
• Maintain organized records of all regulatory documents, submissions, approvals, and communications.
• Attend regulatory seminars and training to stay updated on guideline changes.
• Assist in reviewing basic product labeling to ensure alignment with regulatory standards.
• Coordinate with accredited third-party laboratories for required testing services.
• Perform liaison work for the company with FDA, BAI, and DENR.

Job description

1. Assist in the preparation and compilation pf applications for Licenses to Operate, Certificate of Product Registration, Certificates of Good Manufacturing Practice, and Feed Product Registration with FDA and BAI.

2. Supports the documentation and submission of Laboratory Recognition Certificates, Wastewater Discharge Permits to Operate, and Trademark Registration.

3. Coordinates the timely submission of reports to DENR such as the Self-Monitoring Report (SMR) and Compliance Monitoring Report (CMR).

4. Helps track expirations dates of all company permits and assist in the preparation of renewal documents.

5. Coordinates with regulatory bodies (FDA, BAI, DENR, IPOPHIL) for applications updates and compliance requirements

6.Maintains organized records of all regulatory documents, submissions, approvals, and communications.

7. Attends regulatory seminars and training as assigned to stay updated on changes in regulatory guidelines.

8. Assist in reviewing basic product labelling documentation to ensure to ensure alignment to regulatory standards.

9. Coordinates with accredited third-party laboratories for required testing services.

10. Performs liaison work for the company with the Food and Drug Administration (FDA) Bureau of Animal Industry (BAI), and Department of Environment and Natural Resources (DENR).