Licensed Pharmacist ( at Philippines)

Company : Gufic Biosciences Ltd. (India) — establishing a wholly-owned subsidiary in the Philippines

Position Title : Licensed Pharmacist (Qualified Person / Pharmacist-in-Charge)

Location : Metro Manila, Philippines

Employment Type : Full-time, Permanent

Reporting To : Country Manager / President, Philippines (with dotted-line to Head Regulatory Affairs,

Eligibility : Must be a Filipino citizen and a pharmacist duly licensed by the Professional Regulation

Commission (PRC) Board of Pharmacy

About the Role

Gufic Biosciences Ltd., a leading India-based pharmaceutical manufacturer with a strong international specialty injectable and formulations portfolio, is establishing a wholly-owned subsidiary in the Philippines to serve as its Marketing Authorization Holder (MAH). As mandated under Philippine FDA regulations and the Pharmacy Law (RA 5921), the company requires a duly licensed local Filipino Pharmacist to serve as the statutory Qualified Person / Pharmacist-in-Charge for the new entity. This is a foundational hire for the Philippines operation and will play a central role in company registration, product licensing, and ongoing regulatory and quality compliance.

Key Responsibilities

• Serve as the designated Pharmacist-in-Charge / Qualified Person for the company's License to Operate (LTO) with the Philippine FDA, as required for a drug establishment/MAH.
• Lead and manage end-to-end product registration (Certificate of Product Registration/CPR) filings with the Philippine FDA for the company's pharmaceutical portfolio.
• Ensure full compliance with Philippine FDA Administrative Orders, Circulars, and Pharmacy Law (RA 5921) requirements applicable to drug importation, storage, distribution, and marketing.
• Oversee Good Distribution Practice (GDP) and Good Storage Practice (GSP) compliance at the company's warehouse and distribution facilities.
• Establish and manage the local pharmacovigilance (PV) function, including adverse event reporting, signal management, and liaison with FDA Center for Drug Regulation and Research (CDRR).
• Act as the primary regulatory liaison with the Philippine FDA and other relevant government bodies (BOC, DOH) on behalf of the subsidiary.
• Review and approve product labelling, packaging inserts, and promotional materials for regulatory compliance prior to market release.
• Coordinate with the corporate Regulatory Affairs and Quality Assurance teams in India to align dossier submissions, CMC documentation, and post-approval variations.
• Support due diligence, licensing, and SOP development during the initial set-up phase of the subsidiary, including recruitment of supporting regulatory/QA staff as the entity scales.
• Maintain accurate regulatory records, registration trackers, and renewal timelines to ensure uninterrupted market authorization status

Required Qualifications & Experience

• Bachelor's degree in Pharmacy (BS Pharmacy) from a recognized Philippine institution; a Master's degree is an advantage.
• Valid and active professional license issued by the Professional Regulation Commission (PRC), Board of Pharmacy, Philippines.
• Filipino citizen, in line with statutory requirements for the Qualified Person role under Philippine pharmacy regulations.
• Minimum 5–8 years of relevant experience in regulatory affairs, quality assurance, or pharmacovigilance within a pharmaceutical manufacturing, distribution, or MAH company in the Philippines.
• Demonstrated working knowledge of Philippine FDA product registration processes, LTO/CPR requirements, and ASEAN regulatory frameworks.
• Prior experience supporting a foreign pharmaceutical company's market entry or subsidiary set-up in the Philippines is highly preferred.
• Familiarity with injectable/specialty formulations, anti-infectives, or hospital-line products is an advantage, given the company's product portfolio.

Key Skills & Attributes

• Strong working knowledge of Philippine FDA regulations, AOs, and Circulars, and general familiarity with ASEAN harmonization guidelines.
• Excellent regulatory dossier preparation, documentation, and cross-functional coordination skills.
• High personal integrity and accountability, given the statutory nature of the Qualified Person role.
• Strong communication skills in English, with the ability to liaise confidently with regulators, corporate stakeholders in India, and local business partners.
• Self-starter, comfortable operating in a lean, start-up-style environment during the subsidiary's initial establishment phase.

What We Offer

• An opportunity to be a founding team member of Gufic Biosciences' Philippines subsidiary, with significant ownership and visibility.
• Competitive compensation aligned with local market benchmarks for a statutory Qualified Person role.
• Direct exposure to international regulatory strategy and cross-border collaboration with the corporate team in India.
• Long-term career growth as the Philippines entity scales its regulatory and quality organization.

How to Apply

Interested candidates who meet the above eligibility criteria are invited to submit their updated CV along with a copy of their valid PRC Pharmacist license to the contact details below.

Please indicate "Pharmacist – Philippines Subsidiary" in the subject line.

Deepti Pargaonkar Email : deepti.pargaonkar@guficbio.com