Chief Executive Officer
Dr Boitumelo Semete-Makokotlela is the CEO of the South African Health Products Regulator. She has a Ph.D. (Biochemistry) and also holds MSc in Management Finance and Investment. She is also a fellow of the African Leadership Initiative. Within the technology innovation space, she managed a biotechnology incubator at The Innovation Hub Management Company. She was with McKinsey & Company for two years as a McKinsey Leadership Fellow. Prior to that, she was at the CSIR as a Senior Researcher.
She completed her postdoctoral research at the University of Nottingham and EPFL, Switzerland. She has published as a first author and co-author in scientific publications, review articles and book chapters. She is also involved a number of thought leadership projects such as the African Union Strategy for Health Research, the East Africa Community Bioeconomy strategy development team and WHO Expert Panel on scaling health Innovations in Africa.
Chief Regulatory Officer
Ms Portia Nkambule is a pharmacist with a Masters degree in Public Health. Ms Nkambule studied her B.Pharm degree at the University of Witwatersrand. She received training on Pharmacovigilance at the Uppsala Drug Monitoring Centre in Sweden. She has worked for the Medicines Control Council of South Africa, now the South African Health Products Regulatory Authority (SAHPRA) since 2000. She has extensive experience in medicines registration, variations reviews, clinical trial regulation, bioequivalence protocol reviews, GCP inspections, reviews of unregistered medicines and pharmacovigilance.
Ms Nkambule participated in the reviews of the Medicines and Related Substances Act 101 of 1965 and its regulations, policies and guidelines development. She was appointed by the then Minister of Health, Dr Aaron Motsoaledi, to represent the medicines regulatory authority in the National Health Research Ethics Council (NHREC). She was nominated by SADC Medicines Regulators to represent SADC at the African Vaccine Regulators Forum (AVAREF). Ms Nkambule participated and chaired regulatory sessions at the International Conference of Drug Regulatory Authorities (ICDRA), Developing Countries Vaccines Regulators Network (DCVRN), African Medicines Regulators Conferences (AMRC), the SADC Medicines Regulators Forum and the SADC Zazibona workshops. She also participated at the World Health Organisation (WHO) global benchmarking of other regulatory authorities using the WHO Global Benchmarking Tool. She acted as the Chief Executive Officer of SAHPRA for 22 months. She currently serves in the role of the Chief Regulatory Officer (CRO) of SAHPRA, responsible for providing executive leadership on medicine registration, variations, clinical trials regulation, law enforcement, inspections, licensing, post marketing surveillance, vigilance, medical device regulation and radiation control.
Chief Financial Officer
Mr Regardt Gouws qualified as a Chartered Accountant [CA(SA)] registered with the South African Institute of Chartered Accountants (SAICA). He has more than 17 years of working experience starting at the AGSA and for the past 10 years as CFO. His previous roles were the CFO at various Public Entities (Freedom Park, Film and Publication Board and the Railway Safety Regulator). His contribution as CFO included five clean audits, the successful implementation of financial systems as well as a financial recovery plan.
Executive Manager: Human Resources
Chief Operations Officer
Ms Christelna Reynecke is the COO of South African Health Products Regulatory Authority (SAHPRA). She holds Master of Business Administration (MBA) from the Edinburgh Business School (Heriot Watt University). She also has a BPharm Degree from the University of the North West. In addition, she has been endorsed and certified among others for Business Strategy Execution: Designing Agile Operations, Project Management – Prince2 Foundation, Lean Management for All Sectors, Team Leadership & Management Skills 2020 and Import and Exports Trade Logistics.
With relentless commitment to best practice and an innovative approach to operational improvement, Christelna is passionate about developing and implementing creative solutions that manage business risks, improve operations and secure sustained revenue and reputation. With a key focus on reinforcing corporate fairness, promoting transparency, sustainability and quality, Christelna is a change agent and resourceful and authentic leader.
Over her 21-year career within the healthcare industry she has had the pleasure of working alongside some wonderful colleagues in various roles that she has occupied. From Pharmacist, to Process Manager, Consultant, Responsible Pharmacist, Operations Director and most recently Quality Assurance and Regulatory Director. Most notable projects that she was involved with include SAP systems deployments in the logistics space and a full site construction redevelopment where “acting construction site manager” might have been a more appropriate job title during 2017-2018.
Making a positive impact is what she enjoys most. In her personnel time, she is involved with a garden project that enables the OT department at the hospital to use the space for rehabilitation programmes and the garden also provides fresh produce for the hospital kitchen.
She enjoys growing things. Plants, trees, people, ideas….
“ We should listen to understand, not listen to respond” – she believes in keeping an open mind and moving forward, random acts of kindness, owning your space, being accountable, “anything worth doing, is worth doing well!”, keeping faith and in December possibly also in Santa Clause.
Advocate Mpho Mphelo is the Board Secretary of the South African Health Products Regulatory Authority (SAHPRA). He has over seventeen (17) years of experience in the company secretarial and corporate governance environment. Before working in the company secretarial and governance areas, he worked in student affairs, employee relations, and security and investigations. Before joining SAHPRA, he was the company secretary for the National Health Laboratory Service (NHLS) where he oversaw the Compliance and Legal Department.
He holds B.Proc. and LLB degrees from the University of the North (now University of Limpopo-Turfloop). He has a certificate in a Management Development Programme (MDP Executive Level) from the Gordon Institute of Business Science.
He was admitted as an advocate of the High Court of South Africa since April 2005.