Licensed Pharmacist – Qualified Person (Pharmacy)

About the role

Gufic Biosciences Ltd. is establishing its Philippine subsidiary and seeks a licensed Filipino pharmacist to act as the Qualified Person / Pharmacist‑in‑Charge. This foundational role will ensure regulatory compliance, product registration and quality oversight for the new entity.

Key responsibilities

• Serve as the designated Pharmacist‑in‑Charge / Qualified Person for the company’s License to Operate with the Philippine FDA.
• Lead end‑to‑end product registration (Certificate of Product Registration) filings with the Philippine FDA.
• Ensure compliance with FDA Administrative Orders, Circulars and Pharmacy Law (RA 5921) for drug importation, storage, distribution and marketing.
• Oversee Good Distribution Practice (GDP) and Good Storage Practice (GSP) at warehouse and distribution facilities.
• Establish and manage the local pharmacovigilance function, including adverse event reporting and liaison with the FDA CDRR.
• Act as primary regulatory liaison with the Philippine FDA, BOC and DOH.
• Review and approve product labeling, packaging inserts and promotional materials for regulatory compliance.
• Coordinate with corporate Regulatory Affairs and Quality Assurance teams in India on dossier submissions and post‑approval variations.
• Support subsidiary set‑up activities, including SOP development and recruitment of regulatory/QA staff.
• Maintain accurate regulatory records, registration trackers and renewal timelines.

Required profile

• Bachelor’s degree in Pharmacy from a recognized Philippine institution (Master’s degree is a plus).
• Active pharmacist license issued by the Professional Regulation Commission (PRC) Board of Pharmacy.
• Proven experience in pharmaceutical regulatory affairs, product registration, and compliance with Philippine FDA requirements.
• Experience in pharmacovigilance, GDP/GSP, and handling FDA communications.
• Strong knowledge of the Pharmacy Law (RA 5921) and related administrative orders.

Required skills

• Regulatory affairs and product registration
• Pharmacovigilance and adverse event reporting
• Good Distribution Practice (GDP)
• Good Storage Practice (GSP)
• Labeling and promotional material compliance
• FDA liaison and communication