• Regulatory Officer ensures the appropriate licensing, and legal compliance of pharmaceutical and medical products, in order to control the safety and efficacy of products.

1. Oversees compliance with Food and Drug Administration by submitting the following applications:

• Initial and renewal product registration
• Product variations
• Initial and renewal application for License to Operate

2. Liaises with Food and Drug Administration and other government agencies to facilitate review and approval of applications in a timely manner.

3. Coordinates regulatory submission requirements with the company.

4. Ensures company’s compliance with applicable FDA regulations.

5. Provide regulatory support to Finance, Engineering, and Sales Department.

6. Serves as regulatory affairs support for Pharmacovigilance audit, FDA inspections and internal compliance audit.

7. Attends external seminars and educational sessions to monitor new regulatory updates and to communicate such changes to the President.

8. New Product/s

• Prepares a checklist of requirements based on regulatory agency/ies’ guidelines and requirements
• Collects documentary requirement from Manufacturer/Principal
• Prepares application form/s and necessary attachment/s
• Files application in local regulatory agency
• Upon approval, regulatory officer updates the President
• Safekeeping of the original copies of licenses to proper handling

9. Product/s for renewal registration

• Prepares a checklist of requirements based on regulatory agency/ies’ guidelines and requirements
• Collects documentary requirement from Manufacturer/Principal
• Prepares application form/s and necessary attachment/s
• Files application in local regulatory agency
• Monitors status of application
• Upon approval, updates the President

10. Government mandated registrations for DND operations and for eligibility in joining government biddings

• Prepares a checklist of requirements based on regulatory agency/ies’ guidelines and requirements and monitor the due dates of every permit such as BIR Permits, Business Permits, Mayor’s Permit, Tax Clearance, BOC etc.
• Collects documentary requirement
• Prepares application form/s and necessary attachment/s
• Files application in local regulatory agency
• Monitors status of application
• Upon approval, updates the President

11. Perform other duties as may be assigned by the President

• Monitors status of application

• Graduate of Bachelor of Science in Pharmacy.
• Registered Pharmacist (RPh), with unexpired PRC ID.
• Excellent organizational and planning skills.
• Strong sense of responsibility. Must work with minimal supervision and direction, resourceful, and can work with under pressure.
• Above average computer skills.
• Good communication. Ability to multi-task, organized, attention to details and accuracy.
• Candidate must be willing to work at Greenhills, San Juan City.
• Dynamic fresh graduates are welcome to apply.  
• 1-3 work experience