Regulatory Pharmacist

Sprint Asia Logistics Inc; Antipolo; On-site; PHP 300,000 - 540,000; Full time

Job summary

Sprint Asia Logistics Inc in the Philippines is seeking an FDA Liaison Officer and Coordinating Officer to help gather, monitor, encode and file data, ensuring compliance with FDA requirements and related regulatory standards.

You will coordinate with foreign suppliers, review documents for FDA compliance, manage CPR applications in portals, track renewals, verify product registrations and maintain precise records.

Qualifications

• Registered Pharmacist license and familiarity with FDA processes.
• Fresh graduates are welcome to apply.
• Knowledgeable in FDA processes, 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.
• Willing to be flexibly assigned at ORTIGAS, PASIG and as needed at ANTIPOLO, RIZAL.

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
• Maintain accurate records and documentation needed.

Skills

Regulatory compliance knowledge

Documentation management

Oral and written communication

Attention to detail

Field work willingness

Education

Licensed Pharmacist

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