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

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.

•    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

•    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.

•    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.

•    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.

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 :  [Confidential Information]