Licensed Pharmacist

Detailed Duties and Responsibilities

1. FDA License to Operate (LTO) and Certificate of Good Manufacturing Practice (FCGMP)

* Monitor and implement updates to FDA regulations and ensure compliance with all LTO and FCGMP requirements.

* Review and verify the completeness, accuracy, and compliance of all documents prepared by the Regulatory Affairs Associate prior to submission.

* Prepare, process, and facilitate FDA LTO and FCGMP applications, renewals, and amendments.

* Coordinate with internal departments and the Head Office to ensure timely submission of regulatory requirements.

* Maintain organized records of regulatory licenses, permits, and supporting documentation.

FDA Audit Management

* Coordinate with the FDA regarding audit schedules, objectives, and assigned auditors.

* Gather and prepare all documents and records required for FDA inspections and audits.

* Serve as the company representative during FDA inspections and ensure adherence to the audit process.

* Document audit observations, findings, and inspection reports.

* Review the Minutes of Inspection and communicate findings to the concerned departments.

* Coordinate with the Head Office and cross-functional teams to develop, implement, and monitor Corrective and Preventive Action (CAPA) plans.

* Track the completion of corrective actions and ensure compliance with FDA requirements.

2. FDA Certificate of Product Registration (CPR)

A. Initial Product Registration

* Prepare and maintain product registration checklists in accordance with current FDA regulations and company procedures.

* Review product dossiers, technical documents, and artwork to ensure compliance with FDA requirements and company standards.

* Conduct pre-evaluation of product registration documents before submission.

* Finalize and compile complete product dossiers for FDA submission.

* Process and facilitate FDA applications for new product registrations.

* Coordinate with the FDA regarding application status, document decking, and evaluation progress.

* Monitor and respond promptly to FDA Notices of Deficiency (NOD), Letters of Query, and other regulatory communications.

* Coordinate with the Head Office and relevant departments to obtain additional supporting documents when required.

B. Product Registration Renewal

* Prepare, review, and verify all documents required for CPR renewal.

* Ensure renewal applications comply with current FDA regulations and company policies.

* Submit and facilitate timely renewal applications to prevent product registration lapses.

* Monitor renewal status and coordinate with the FDA until approval is obtained.

C. Amendment, Variation, and Post-Approval Compliance

* Prepare and review all documentary requirements for product amendments, variations, and post-approval changes.

* Ensure all changes comply with FDA regulations and company quality standards.

* Compile and finalize regulatory dossiers for submission.

* Process and facilitate amendment and variation applications with the FDA.

* Monitor application progress and coordinate responses to FDA inquiries or additional requirements.

* Maintain updated regulatory records for all approved amendments and post-approval commitments.

3. Intellectual Property Office (IPO)

* Review, verify, and finalize all Intellectual Property Office (IPO) documents prepared by the Regulatory Affairs Associate.

* Ensure the completeness, accuracy, and compliance of all documentary requirements prior to submission.

* Prepare, process, and facilitate trademark and other applicable IPO applications, renewals, and related filings.

* Monitor application status and coordinate with the IPO regarding updates, requirements, and approvals.

* Maintain organized records of all IPO registrations and related documents.

4. Bioassay (CEDRES)

* Coordinate with the Head Office and CEDRES regarding assay methods, testing requirements, and applicable procedures.

* Review, verify, and finalize all bioassay documents prepared by the Regulatory Affairs Associate before submission.

* Monitor the status of bioassay applications and laboratory testing requirements.

* Upon receipt of a Notice of Deficiency (NOD), immediately coordinate with the Head Office and request the necessary supporting documents and data within three (3) working days.

* Ensure timely submission of responses and supporting documents to prevent delays in product registration.

5. Shipment Coordination

* Coordinate with the Head Office and third-party logistics providers to obtain all required shipment and importation documents.

* Ensure the completeness and accuracy of shipment documentation prior to product release.

* Monitor shipment schedules and delivery status from dispatch to arrival.

* Coordinate with third-party logistics providers regarding Shipment Receiving Reports and other shipment-related documentation.

* Maintain complete records of shipment transactions and regulatory documents.

6. Product Destruction

* Prepare and finalize the product destruction list for approval by the Head Office.

* Coordinate with the FDA regarding product destruction requirements, approvals, and inspection schedules.

* Prepare and submit all documentary requirements related to product destruction in compliance with FDA regulations.

* Coordinate with the Finance and Accounting Department, Internal Control Department, Royal Cargo, RBC, and other concerned parties regarding the approved destruction schedule.

* Facilitate and oversee the actual product destruction process to ensure compliance with FDA requirements.

* Prepare and submit post-destruction documentation and compliance reports to the FDA.

* Maintain complete records of all product destruction activities and regulatory approvals.

7. PRC Training for Medical Representatives

* Prepare all documentary requirements and application forms necessary for PRC-accredited Medical Representative training and certification.

* Coordinate with the Human Resources Department and the Head Office in preparing the proposed training program, participant list, and budget.

* Facilitate the submission of PRC training applications and ensure compliance with all regulatory requirements.

* Coordinate with the PRC regarding application status, training schedules, and certification requirements.

* Maintain updated records of Medical Representative certifications and training compliance.

8. Local Purchase of Product Samples

* Coordinate with the Head Office regarding the approved list of products for local purchase as samples.

* Facilitate the procurement of approved product samples in accordance with company policies and regulatory requirements.

* Ensure that all purchases are properly documented and supported by the required approvals.

* Coordinate with the Finance and Procurement teams regarding payment processing and documentation.

* Maintain accurate records of purchased samples and their distribution for regulatory and internal audit purposes.