Nthabiseng Lephatsoana is a registered pharmacist with more than 18 years of experience in the pharmaceutical and vaccine manufacturing industry, spanning sterile production, quality systems, product release, regulatory affairs, and Responsible Pharmacist governance.

As Biovac’s Responsible Pharmacist and Head of Regulatory Affairs, she leads regulatory compliance, product lifecycle management, quality oversight, pharmacovigilance, and engagement with national and international regulatory authorities.

Her career includes sterile manufacturing roles at Aspen Pharmacare and Fresenius Kabi. -At Biovac, she progressed from leading Quality Assurance Systems to her current role, with responsibility for vendor and contract manufacturer management, audits, product quality reviews, recalls, inspections, and the release of vaccines and other biological products.

Nthabiseng is passionate about strengthening regulatory systems that support vaccine sovereignty and sustainable access across Africa. She has contributed to regulatory strategy, quality governance, inspection readiness, and stakeholder engagement involving regulators, manufacturers, and public health partners.

She holds a Bachelor of Pharmacy degree from Nelson Mandela Metropolitan University, a BSc Honours in Human Physiology from the University of the Western Cape and has completed advanced management and quality assurance programmes.