Regulatory Affairs Specialist  

Role Overview

As the Regulatory Affairs Specialist at Healthspan Global, you are responsible for the legal and clinical compliance of our entire product portfolio. You will serve as the primary link between our international partner brands (from the US, Europe, and Asia) and the Philippines FDA. Your mission is to ensure that every aesthetic device, cosmetic, and medical solution we distribute is fully registered, renewed, and compliant with national health standards.

Job Brief

We are looking for a meticulous and detail-oriented Regulatory Affairs professional to lead our product registration and compliance efforts. You will manage the end-to-end lifecycle of our technical dossiers—from reviewing initial clinical data provided by our global partners to securing the final License to Operate (LTO) and Certificate of Product Registration (CPR) or Notification (CPN). Your work ensures that our sales team can operate with total confidence and that our clinic partners receive only the highest quality, legally cleared innovations.

Key Responsibilities

• FDA Liaison & Registration: Own the full registration process for medical devices, cosmetics, and health products. Lead the preparation, submission, and monitoring of all applications via the FDA e-Services/e-Portal.
• Global Partner Collaboration: Work closely with the regulatory and R&D teams of our international partner brands. Review and assess foreign technical dossiers, Certificates of Free Sale (CFS), and Good Manufacturing Practice (GMP) certificates to ensure they meet Philippine standards.
• Compliance Lifecycle Management: Proactively manage the renewal of all establishment licenses (LTO) and product registrations. Track expiration dates to ensure zero "gap" in market availability.
• Document Review & Assessment: Critically evaluate clinical data, labeling, and promotional claims. Ensure all packaging and marketing materials are compliant with FDA labeling requirements and the ASEAN Cosmetic Directive (ACD).
• Regulatory Intelligence: Stay updated on the latest FDA Administrative Orders and circulars. Advise management on how changes in Philippine regulations may impact our upcoming product launches or current inventory.
• Post-Market Surveillance: Assist in managing any product-related safety reports or adverse event reporting as required by the Department of Health (DOH).

Requirements & Qualifications

• Professional Background: A licensed Pharmacist is highly preferred (to serve as the Qualified Person / Pharmacist of Record for the FDA), but candidates with degrees in Life Sciences, Biology, or Chemistry with significant RA experience will be considered.
• Experience: 3+ years of experience in Regulatory Affairs within the Philippines Medical Aesthetic, Pharmaceutical, or Medical Device industries.
• Technical Knowledge: Deep familiarity with the FDA Philippines e-Portal system, LTO/CPR/CPN application processes, and the ASEAN Cosmetic Directive.
• Analytical Skills: Strong ability to read and interpret technical documents and clinical trials from international sources.
• Communication: Excellent command of English (written and verbal) to effectively communicate with international brand partners and government evaluators.
• Location: Based in Makati, with the ability to visit the FDA (Alabang) or other government offices as needed.