Regulatory Affair Pharmacist

Sprint Asia Logistics Inc; Metro Manila; Hybrid; PHP 250,000 - 450,000; Full time

Job summary

Sprint Asia Logistics Inc seeks an FDA Liaison Officer/Coordinating Officer to ensure compliance with FDA regulations in the Philippines. The role involves coordinating with foreign suppliers, reviewing regulatory documents, and managing product registrations to maintain timely compliance with FDA requirements.

Fresh graduates are welcome. Ideal candidates are registered pharmacists with knowledge of FDA processes, strong communication skills, and attention to detail, willing to perform field

Qualifications

• Registered Pharmacist with valid license.
• Fresher graduates welcome to apply.
• Knowledgeable in FDA processes and regulations.
• Well-informed regarding regulatory compliance and standards.
• Familiar with pharmaceutical principles and procedures.
• Experience in product registration with FDA is a plus.
• Good oral and written communication skills.
• Detail oriented.
• Can do field work if needed.

Responsibilities

• Coordinate with foreign suppliers for FDA requirements.
• Check documents for FDA regulatory compliance.
• Apply CPR in the portal/Website.
• Monitor near CPR expiry for renewal.
• Check product for Initial and Amendment.
• Application & renewal of Certificate of Product Registration; ensure timely compliance to FDA.
• Collaborate with foreign suppliers for required FDA documentation.
• Maintain accurate records and documentation.

Job description

Job description

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

• Fresh Grad are welcome to apply

• 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 flexibly assigned at ORTIGAS, PASIG and as needed at ANTIPOLO, RIZAL