Lyza Furigay

Registered Regulatory Affairs Pharmacist with over 10 years of experience across distribution, pharmaceutical manufacturing, and international importation, with strong expertise in Philippine FDA compliance and end-to-end product lifecycle management. Specializes in regulatory strategy, dossier execution, and post-approval maintenance, consistently ensuring timely approvals and sustained compliance. Proven ability to drive cross functional and international collaboration, working with global teams and key stakeholders to support successful product commercialization.

Skilled in regulatory intelligence, audit and inspection readiness, and CAPA, with a demonstrated track record of optimizing regulatory systems and streamlining workflows to improve efficiency, visibility, and approval timelines.

Assistant Regulatory Manager at Vexxa Lifesciences Pvt. Ltd. (2023-06 – Present)

• Manage regulatory affairs activities for pharmaceutical products, ensuring compliance with Philippine FDA regulations and ACTD requirements.
• Handle product registrations, renewals, variations, notifications, and post-approval regulatory submissions for imported pharmaceutical products.
• Prepare, review, and compile regulatory dossiers including CTD/ACTD documentation, technical data, and supporting compliance requirements.
• Coordinate with international regulatory partners for submission documents such as GMP certificates, COAs, FSCs, MSDS, BE studies, and stability data.
• Review and approve packaging artworks, labeling materials, and product inserts to ensure compliance with FDA labeling regulations.
• Facilitate regulatory submissions for hospital product inclusion and institutional accreditation requirements.
• Liaise with internal departments including Quality Assurance, Warehouse, Marketing, Finance, and International Regulatory Teams to support product commercialization and compliance activities.
• Monitor FDA application progress, compliance commitments, payment processing, and regulatory documentation tracking.
• Support regulatory inspections, CAPA implementation, and continuous compliance improvement initiatives.
• Assist in maintaining regulatory databases, document control systems, and submission records.
• Contribute to successful market access and regulatory maintenance of pharmaceutical products in the Philippine market.

Regulatory Affairs Supervisor / Quality Assurance at DIAMOND LABORATORIES INC. (2017-05 – 2023-06)

• Ensures that all scheduled transactions with governing bodies are being monitored and done.
• Ensures that activities of Regulatory Section are being done as scheduled.
• Ensures that all deficiencies are timely complied and submitted.
• Checks and proof reads the documents for FDA, DOH, BAI, PDEA, HALAL submission.
• Reviews the field accomplishment folder of the Regulatory Officer and updates database and/or makes necessary instructions.
• Coordinates with QA Manager the following: A. Certain slow moving and non-moving products; B. Products requiring expensive study (still for renewal or not); C. Updates from FDA on Circulars, Memoranda, AOs, Advisories etc.; D. Updates on new requirements.
• E. Updates on Projects with clients as to CPR regulatory concerns.
• F. Oversees monitoring of CPRs, LTOs, Notifications, Promo Permits, Halal validity etc.
• Applies and/or assigns application of new LTO.
• Applied and/or assigns renewal application of LTOs.
• Applies and/or assigns Variation Application or Corrections to LTO as to: - Change in business name & address of manufacturer/trader/importer/distributor - Change/deletion or inclusion of activity - Etc.
• Monitors timely documentation of CPR applications and initial applications
• Monitors the timely compliance of Notice of Deficiency, PMS requirement and Exhaustion Notices received from FDA.
• Applies and/or assigns Variation applications on the MAH, product, process and/or packaging materials
• Responsible in checking the correctness of details in the issued CPR by FDA and make further correction request/s to FDA.
• Responsible in the preparation and/or assignment of promotional permits to FDA.
• Responsible in monitoring Promo Permit Validities
• Coordinates with client to whether Promo Permit is for extension or not.
• Applies and/or assigns application for Certificate of Exemption
• Communicates with the Toll Clients on Regulatory concerns such as CPR renewal schedule and payment.
• Coordinates with PDEA Pharmacist in charge for the submission of Consumption Report and Renewal of License.
• Coordinates with QC on products and for raw materials for outside testing as requirement in FDA application specially for new products.
• Regularly updates QA Manager on important issues pertaining Regulatory activities
• Delegates the application of reissuance as per client's request.
• Checks and monitors orderliness and proper filing of all receiving copies to their corresponding folder to maintain updated and completeness of Protocols, CPRs and LTO.
• Responds to Product Verification as requested by FDA
• Responsible in monitoring of transactions awaiting approvals.

Company Pharmacist / Regulatory Affairs Officer at LEWISON PHARMACEUTICALS CORPORATION (2014-07 – 2017-02)

• Ensuring company's product complies with the regulations of the FDA preparing submissions of license variations and renewals.
• In charge of the renewal and registrations of the products, in compliance with FDA rules and regulations.
• Regularly visit FDA to monitor any alteration in registration procedures and requirement.
• Develop packaging for new and existing products and comply with government regulation.
• Regular coordination with the assigned evaluator to know the status of the submitted documents and know any lacking document.
• Developing and writing clear arguments and explanations for new product licenses.
• Planning and developing product trials and interpreting trial data;
• Undertaking and managing regulatory inspections.
• Reviewing company practices and providing advice on changes to systems;
• Negotiating with regulatory authorities for marketing authorization; specifying storage, labeling and packaging requirements and Suppliers of packaging materials and raw materials.
• Handle monitoring stocks, maintaining level inventory & proper storing of company products.
• Check the stock item wise against the invoice for correctness of the name, strength and expiry of the medicine. Perform expiry checks as well as during dispensing.
• Conduct Product knowledge for our clients and medical representative.
• Physical inventories and Product ordering of packaging materials and raw materials.
• Attend continuing education seminars to keep FDA policies and procedures for the company.

Bachelor of Science in Pharmacy – Our Lady of Fatima University (2014)