Regulatory Pharmacist

About the role

The role is 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.

Key responsibilities

• Coordinate with foreign suppliers for FDA requirements
• Check documents for compliance with FDA regulatory standards
• Apply CPR in the portal/Website
• Monitor near CPR expiry for renewal
• Check product for initial and amendment
• Application and renewal of Certificate of Product Registration
• Ensure the company's timely and proper compliance to FDA
• Collaborate and communicate with foreign suppliers for required documentation
• Maintain accurate records and documentation needed

About you

• 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
• Relevant experience in product registration with FDA
• Good oral and written communication skills
• Detail oriented
• Can do field work if needed
• Willing to be flexibly assigned at ORTIGAS, PASIG and as needed at ANTIPOLO, RIZAL