Regulatory Affair Pharmacist

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.

• 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
• Willing to be assigned at ANTIPOLO, RIZAL