Roster of Consultants - Regulatory Systems Strengthening, Local Production Ecosystem Support, Technology Transfer %26 Technical Assistance Coordination
Organizational Context
The WHO AFRO is establishing an integrated Consultant Roster to support Member States in strengthening regulatory systems, local production, manufacturing ecosystems, technology transfer, and technical assistance coordination for medicines, vaccines, diagnostics, medical devices, and other health technologies. This roster aims to rapidly deploy qualified experts to enhance these critical areas across the region.
Job Purpose
The purpose of this consultancy roster is to build a pool of qualified experts who can be rapidly deployed by WHO AFRO to support Member States. These experts will focus on strengthening regulatory systems maturity, advancing harmonization and reliance mechanisms, and improving local production and manufacturing ecosystems. They will also support technology transfer pathways and coordinate technical assistance in collaboration with key partners like Africa CDC and AUDA NEPAD. The ultimate goal is to develop national and regional strategies, policies, and roadmaps to enhance health technology access and self-sufficiency within the African region.
Responsibilities
Consultants will be responsible for a range of duties depending on their specialization. This includes strengthening national regulatory policy, legislation, and governance frameworks; conducting GMP inspections and developing related tools; assessing dossiers for medicines, vaccines, diagnostics, and devices; enhancing laboratory capacity and quality control; and supporting the digitalization of regulatory systems. For those focused on local production, responsibilities involve leading the implementation of production frameworks, coordinating technical assistance, conducting ecosystem assessments, developing costed roadmaps, facilitating technology transfer, and supporting manufacturers in achieving GMP/PQS compliance and WHO PQ readiness. Training of national regulatory authority staff and laboratory personnel is also a key function.
Work Experience
Required experience includes a minimum of 7 years for technical specialists in regulatory systems strengthening or local production categories, and 10+ years for senior coordination experts. Experience should be relevant to the specific role, such as policy development, GMP inspections, dossier assessment, laboratory systems, digitalization, or manufacturing ecosystem strengthening.
Skills
Key skills include strong analytical, facilitation, and report writing abilities. Expertise in WHO quality assurance standards, ability to collaborate with governments and regulatory bodies, and excellent communication and stakeholder engagement skills are essential. Specific technical skills will vary based on the consultant category, encompassing areas like regulatory policy, GMP, quality management systems, dossier assessment, laboratory quality control, digitalization, and AI applications in regulatory processes.