Speaker Profile

BIOGRAPHY

Kudzai Leona Mkhau is a regulatory affairs pharmacist at Varichem Pharmaceuticals (Pvt) Ltd, where she leads regulatory strategy, compliance, and stakeholder engagement across the product lifecycle. She holds a Bachelor of Pharmacy from the University of Zimbabwe, an MSc in International Public Health from Liverpool John Moores University, and a PGDip in Global Health Procurement and Supply Chain Management. She is currently pursuing a master’s in biotechnology innovation and regulatory science with Purdue University, equipping her with advanced tools to navigate and shape Africa’s evolving regulatory landscape.
Kudzai played a pivotal role in Varichem’s participation in the Continental Pilot on Listing of Human Medicinal Products, a landmark initiative under the African Medicines Regulatory Harmonisation (AMRH) framework. Her contributions included coordinating dossier submissions, aligning GMP documentation with continental standards, and facilitating regulatory dialogue across jurisdictions. Varichem’s successful engagement in the pilot led to a historic milestone, becoming the first African pharmaceutical manufacturer to have a product officially listed through the continental listing procedure, setting a precedent for regional regulatory integration and industry excellence.
Prior to joining Varichem, Kudzai served at the Medicines Control Authority of Zimbabwe, where she gained extensive experience in product registration, GMP inspections, and regulatory enforcement. She is a member of The Organisation for Professionals in Regulatory Affairs (TOPRA) and the Pharmaceutical Society of Zimbabwe (PSZ) and has completed specialised training in regulatory leadership, systems thinking and GMP through Purdue University and GIZ.
Her work reflects a commitment to strengthening regulatory systems and improving access to safe, effective and quality-assured medicines across Africa.