Consultant-senior Regulatory Reviewer (Avaref Clinical Trial Pilot)
Organizational Context
The WHO's AVAREF initiative aims to enhance Africa's capacity for research and development of medicines and vaccines by strengthening regulatory systems. The AVAREF Clinical Trial Pilot project, involving 16 member states, seeks to improve regulatory and ethical review processes for clinical trials through harmonization, capacity building, and the development of a digital platform. This role supports the pilot project by providing expert review and mentorship.
Job Purpose
The Consultant Senior Regulatory Reviewer will play a crucial role in the AVAREF Clinical Trial Pilot project, focusing on strengthening the regulatory oversight of clinical trials across 16 African member states. This position involves providing expert mentorship, coaching, and second-level review for a pool of 48 nominated reviewers, particularly on the clinical components of trial applications. The goal is to enhance the quality and timeliness of regulatory decisions, support multi-country joint reviews, scientific advice, and facilitated registrations, ultimately contributing to the AVAREF's strategic objective of attracting more clinical trials to the African continent and harmonizing regulatory frameworks.
Responsibilities
Provide training, mentorship, and coaching to reviewers on the clinical evaluation of clinical trial applications. Support the development and refinement of updated guidelines, Standard Operating Procedures (SOPs), and checklists for clinical trial reviews. Assist in ongoing multi-country joint reviews, scientific advice processes, and facilitated registrations for clinical trials and emergency use authorizations. Develop and deliver training workshops focused on comprehensive clinical trial application review and assessment report writing. Contribute to the modernization of AVAREF's regulatory processes, including harmonization and standardization efforts. Perform other related functions as assigned by the AVAREF Coordinator.
Work Experience
Essential: Minimum of 10 years of significant experience working in an internationally recognized national regulatory agency (ML-4). This includes extensive experience in the regulation of medicines (vaccines, biotherapeutics, pharmaceuticals, advanced therapeutics, diagnostics), review of clinical trial dossiers, and registration of new/existing medicines. Experience in regulating biotherapeutics and biosimilars is also required. Desirable: Demonstrated experience in medicines review and approval processes within a leading regulatory agency, and experience working in Africa or other low- and middle-income countries.
Skills
Expertise in reviewing non-clinical and clinical data for registration dossiers. Knowledge of Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), and Good Manufacturing Practice (GMP). Experience in post-marketing surveillance, biostatistics, pharmacovigilance, or pharmacoepidemiology. Strong analytical, deductive, and writing skills. Excellent communication and project delivery capabilities. Ability to work effectively in a team under tight deadlines. Proficiency in data collection tools, statistical packages, communication software, and Microsoft applications (Excel, Word, PowerPoint). Knowledge of project management software.