Regulatory Specialist

We are seeking a highly organized and detail-oriented Regulatory Project Coordinator / Manager to be the central point of contact between our Head Office (HO) and our Emerging Market country teams. This critical role ensures the seamless and timely delivery of all regulatory, technical, and administrative documentation required for product registration, dossier submissions, and market entry across various international territories.

Key Responsibilities :

I. Documentation & Legal Coordination

• Central Document Management : Coordinate the preparation, notarization, and Apostillization of essential legal and administrative documents, including Power of Attorneys (POAs), Letters of Authorization (LOAs), Good Manufacturing Practice (GMP) Certificates, Certificates of Pharmaceutical Product (CoPP), and Free Sale Certificates (FSC).
• Technical Documentation : Collaborate with the Regulatory Affairs (RA) team to compile, organize, and get technical documents (e.g., Qualitative & Quantitative (Q&Q) data) apostilled.
• Dispatch Management : Manage the timely preparation and dispatch of all hard-copy documents and samples to country-based regulatory teams.

II. Cross-Functional Project Management

III. Compliance, Due Diligence & Market Support