Regulatory Officer - Antipolo Base

The Food and Drugs Administration responsible for gathering, monitoring, finalizing, encoding and filing necessary data submitted and/or received from FDA (FDA Liaison Officer and Coordinating Officer).

Supports the company in ensuring compliance with international and local regulatory standards.

Responsibilities:
Coordinate with foreign suppliers for FDA requirements
Checking documents if complied with FDA regulatory
Apply CPR in the portal/ Website
Monitoring near CPR expiry for renewal
Check product for: Initial and Amendment
Application & renewal of Certificate of Product Registration. Ensure the company’s timely and proper compliance to FDA
Collaborate and communicate with foreign suppliers for the required documentation (if complied with FDA regulatory)
Maintain accurate records and documentation needed.

Qualifications:
- Registered Pharmacist
- Knowledgeable in FDA (Food and Drug Administration) process, laws and regulations
- Well-informed regarding regulatory compliance and standards
- Familiar with pharmaceutical principles and procedures
- with relevant experience in product registration with FDA
- good oral and written communication skills
- detail oriented
- can do field work if needed