**Background**
Regulatory scientists in sub-Saharan Africa is the population being studied in this research.
There is no documentation in the literature of competencies required of regulatory scientists in sub-Saharan Africa. However, the literature shows that inadequate competent regulatory scientists is a challenge to ensuring safe, quality and effective medical products in sub-Saharan Africa (Drugs for Neglected Diseases initiative, 2013; Ekeigwe, 2019; Ndomondo-Sigonda, Miot, Naidoo, Dodoo, & Kaale, 2017; World Health Organization, 2019). Despite efforts by developmental agencies such as the WHO, United Nations Industrial Development Organization (UNIDO), to train regulatory scientists, the problem still persists as noted in the 2019 report of Mckinsey & Company on “Should sub-Saharan Africa makes its own drugs” (Conway, Sabow, & Sun, 2019). Insufficient competent regulatory scientists in sub-Saharan Africa is a persistent problem and there is a dearth of academic research in developing the competences of regulatory scientists in sub-Saharan Africa.
Competency frameworks are the substrate for effective development of the capacity of regulatory scientists and any other profession. (Drago, Shire, & Ekmekci, 2016). The absence of a competency framework has resulted in a wide skills range among regulators in sub-Saharan Africa; NMRAs are not at the same level in the regulation of medical products and difficulty in the ‘portability’ of regulatory scientists in the region. This in turn leads to huge variations in the efficient and effective regulation of medical products and therefore impairs access to safe, quality and effective medicinal products. (World Health Organization, 2010). Therefore, it is important to describe the competences required of regulatory scientists in sub-Saharan Africa. This will serve as a template for developing curriculum, training, and recruitment processes. This review will focus on the competencies for regulatory scientists (regulators/regulatees) involved in the registration and inspection of medical products.
