Click here to Apply Department Regulatory Management and R & D – AL Job Description Prepare product registration / renewal dossiers according to the regulatory requirements of MOH - Overseas using ACTD / ICH – CTD and / or relevant regulatory guidelines. Prepare product variation applications using ACTD / ICH – CTD and / or relevant regulatory guidelines. Prepare query compliance documents for submission to MOH – Overseas. Coordinate with QA & Compliance / QC / R&D / Validation for any inquiry on Manufacturing Process and Testing Method. Prepare monthly plan, minutes of meeting and progress trend analysis. Prepare initial text of insert and composition of artworks for registration & commercialization purpose. Assist in preparation of change alerts for any change in regulatory management system. Education Pharm-D from an accredited University Experience 1 to 2 Years of Pharmaceutical Regulatory experience Skills Must have knowledge of basic regulatory requirements ...
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