Speaker Profile

BIOGRAPHY

Dr Esther Mokaya is a seasoned regulatory affairs and quality assurance professional with over a decade of experience focused on achieving regulatory harmonisation and compliance across Sub-Saharan African markets.
Currently serving as the Regulatory Affairs & Quality Assurance Manager for East Africa at Roche Kenya Limited (Diagnostics Division), she leads critical functions, including managing submission of new applications for MD/IVD registration and post-approval changes, as well as implementation of robust Quality Management Systems (QMS) aligned with ISO standards. Her strategic leadership has previously been instrumental in managing multi-territory regulatory submissions for major pharmaceuticals, successfully navigating complex regulatory landscapes across Sub-Saharan Africa.
Dr Mokaya holds a Master of Pharmacy (Pharmaceutical Analysis) and actively contributes to industry harmonisation efforts as the Committee Lead for Trade Policy and Regulatory at the Medical Devices Association of Kenya (MEDAK). She is also an active member of the Kenya Association of Pharmaceutical Industries (KAPI) and the Medical Technology Association of the Middle East & Africa (Mecomed). Beyond her technical expertise in regulatory affairs and quality assurance, she is an avid reader who uses her passion for continuous learning to anticipate and successfully implement evolving regulations.