Mary Mgwatu Masanja is a pharmacist and regulatory expert with over 30 years of experience in medicines, medical devices, and diagnostics regulation. She has extensive expertise in pharmacovigilance, post-marketing surveillance, product registration, GMP inspections, and quality assurance of medical products.

She previously served as Manager, Vigilance and Post Marketing Surveillance at the Tanzania Medicines and Medical Devices Authority (TMDA), where she led regulatory oversight of medical devices, diagnostics, and blood products. Throughout her career, she has held several senior positions at TMDA and has contributed to strengthening regulatory systems, conducting inspections of pharmaceutical manufacturing facilities, and supporting regional regulatory harmonization initiatives.