Regulatory Affairs Specialist – Nhân Viên Đăng Ký Thuốc, Từ 3 - 5 Năm Kinh Nghiệm

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We are seeking a highly competent Regulatory Affairs Specialist to manage regulatory activities for imported pharmaceutical products in Vietnam. The role involves end-to-end responsibility for drug registration lifecycle, regulatory strategy, and post-marketing compliance, ensuring alignment with Ministry of Health (MOH) regulations and international pharmaceutical standards. KEY RESPONSIBILITIES: • Review and evaluate CTD dossiers and legal documentation for imported pharmaceutical products, ensuring full compliance with current regulations and guidelines issued by the Drug Administration of Vietnam (DAV) – Ministry of Health. • Prepare administrative documentation in accordance with applicable circulars and regulatory requirements; coordinate closely with overseas manufacturers to compile complete registration dossiers. • Review, prepare, and submit GMP documentation for manufacturing site assessment and regulatory evaluation. • Monitor and interpret regulatory updates including circulars, decrees, and product labeling requirements, ensuring timely internal implementation. • Track registration progress and manage deficiency responses by preparing accurate supplementary documentation until marketing authorization is granted. • Manage post-approval activities including variations, supplements, and dossier updates as required by regulatory authorities. • Prepare and submit renewal applications prior to registration expiry to ensure continuous product compliance. • Perform other Regulatory Affairs activities as assigned by line management. • Ngày làm việc: T2 - T7 • Giờ làm việc: 08:30 - 17:30 • Cấp bậc: Có kinh nghiệm • Loại công việc: Toàn thời gian