Regulatory Pharmacist - FDA Submissions & Compliance Lead

I-Senz Medical Inc.; Manila; On-site; PHP 600,000 - 900,000; Full time

Job summary

I-Senz Medical Inc. in Manila, Philippines, is seeking a Regulatory and Company Pharmacist responsible for submission, follow-up, renewal, maintenance, amendments, and updates of product registrations with the FDA.

You will safeguard technical documents, coordinate with the President and CEO on application details, oversee QA activities with contract manufacturers, review labeling, handle adverse reactions reporting, and ensure compliance across licensing and importation processes.

Responsibilities

• The Regulatory and Company Pharmacist is responsible for the submission, follow-up, renewal, maintenance, amendments, and updates of product registrations. Ensures the proper and confidential safekeeping of technical product documents, including Certificates of Product Registration, licenses, and permits.
• Collates and submits documents for initial product registration in compliance with FDA requirements.
• Maintains product registrations, including amendments, product improvements, and updates.
• Coordinates with the President and CEO on product application details required by the FDA.
• Oversees QA activities, including coordination with contract manufacturers and handling product complaints.
• Reviews packaging and promotional materials for compliance with FDA labeling requirements.
• Handles product registration applications from filing to FDA approval.
• Secures licenses and permits for the importation of medical samples and commercial goods, when applicable.
• Reports relevant government issuances from DOH, DDB, FDA, and other agencies.
• Maintains and safeguards confidential regulatory records, including CPRs, licenses, permits, and technical documents.
• Ensures timely reporting of adverse reactions in accordance with FDA requirements.
• Validates order details, including quantity, recipient, and expiration dates, before shipment.
• Monitors product expiry dates and ensures proper stock rotation using the FEFO system.

Job description

I-Senz Medical Inc. in Manila, Philippines, is seeking a Regulatory and Company Pharmacist responsible for submission, follow-up, renewal, maintenance, amendments, and updates of product registrations with the FDA.

You will safeguard technical documents, coordinate with the President and CEO on application details, oversee QA activities with contract manufacturers, review labeling, handle adverse reactions reporting, and ensure compliance across licensing and importation processes.