Roster of Consultants - Regulatory Systems Strengthening, Local Production Ecosystem Support, Technology Transfer & Technical Assistance Coordination, Brazzaville, Congo

## Roster of Consultants - Regulatory Systems Strengthening, Local Production Ecosystem Support, Technology Transfer & Technical Assistance Coordination, Brazzaville, Congo - Organization:WHO - World Health Organization - Office:WHO Brazzaville, Congo Roster of Consultants Regulatory Systems Strengthening, Local Production Ecosystem Support, Technology Transfer & Technical Assistance Coordination Contractual Arrangement : External consultant Contract Duration (Years, Months, Days) : The consultancy contract duration varies from 1 to 11 months, depending on the need. Job Posting: Sep 7, 2026, 11:49:25 AM WHO AFRO is establishing an integrated Consultant Roster to support Member States in strengthening regulatory systems, local production, manufacturing ecosystems, technology transfer (TT), and technical assistance (TA) coordination for medicines, vaccines, diagnostics, medical devices, and other health technologies. PURPOSE OF THE CONSULTANCY ROSTER The roster will enable WHO AFRO to rapidly deploy qualified experts to: - Strengthen regulatory systems maturity using the WHO Global Benchmarking Tool (GBT) - Advance harmonization, reliance, convergence, and institutional development plans - Strengthen local production ecosystems, GMP/PQS compliance, and WHO PQ readiness - Support technology transfer pathways (including TRL 4-7 identification) - Coordinate technical assistance in collaboration with Africa CDC, AUDA NEPAD, RECs, AMA, and other partners - Develop national and regional strategies, policies, tools, and costed roadmaps CONSULTANT CATEGORIES and SUMMARY ROLES Below are summary roles for each category to guide applicants. A. REGULATORY SYSTEMS STRENGTHENING CATEGORIES 1. POLICY, LEGAL & REGULATORY GOVERNANCE EXPERTS (7+ YEARS) Strengthen national regulatory policy, legislation, governance, and institutional frameworks. Support harmonization, reliance, and regulatory coherence. - Review and update medicines/health technologies laws - Strengthen NRA governance and decision-making systems - Align national policies with WHO standards - Support development of regulatory strategies and IDPs 2. GMP, LICENSING & MANUFACTURING OVERSIGHT EXPERTS (7+ YEARS) Improve regulatory oversight of manufacturing sites through GMP inspections, licensing system strengthening, and manufacturer readiness support. - Conduct GMP inspections and coached audits - Develop GMP SOPs, inspection tools, licensing procedures - Train inspectors and support competency development - Support regional work sharing and harmonized GMP approaches 3. QMS, DOSSIER ASSESSMENT & REGULATORY PROCESSES EXPERTS (7+ YEARS) Strengthen regulatory quality systems and improve dossier assessment processes for medicines, vaccines, diagnostics, and medical devices. - Implement and strengthen QMS/PQS across regulatory functions - Conduct dossier assessments (CTD, PQ, diagnostics, devices) - Support reliance pathways and collaborative procedures - Train NRA staff on assessment and QMS 4. LABORATORY SYSTEMS & QUALITY CONTROL EXPERTS (7+ YEARS) Enhance national QC laboratory capacity, accreditation readiness, testing methodologies, and data governance. - Conduct laboratory capacity assessments - Support ISO/IEC 17025 accreditation - Improve testing methodologies and data governance - Train laboratory personnel 5. DIGITALIZATION, DATA GOVERNANCE & AI EXPERTS (7+ YEARS) Support digital transformation of regulatory systems through workflow digitalization, data governance, and AI enabled regulatory analytics. - Develop digital platforms for regulatory workflows - Implement data governance frameworks - Apply AI tools for PV, dossier screening, analytics - Train NRA staff on digital tools B. LOCAL PRODUCTION & ECOSYSTEM STRENGTHENING CATEGORIES 1. SENIOR LOCAL PRODUCTION & TECHNICAL ASSISTANCE COORDINATION EXPERTS (10+ YEARS) Provide strategic leadership and coordination of technical assistance for local production, ecosystem strengthening, technology transfer, and regional manufacturing development. - Lead implementation of the Local Production Framework (2025-2035) - Coordinate TA missions across WHO AFRO in collaboration with Africa CDC, AUDA NEPAD, RECs, AMA, and other partners - Conduct country profiling, ecosystem diagnostics, and regional manufacturing/R&D mapping - Facilitate TT pathways, including TRL 4-7 identification and absorptive capacity assessments - Support industrial policy, regulatory coherence, and governance strengthening - Lead development of costed roadmaps, KPIs, MEL frameworks - Mobilize resources and support investment cases - Produce high level briefs, donor materials, and RC/SMT reporting 2. ECOSYSTEM ASSESSMENT & ROADMAP DEVELOPMENT EXPERTS (7+ YEARS) Conduct ecosystem assessments and develop sequenced, costed national or regional roadmaps for manufacturing ecosystem strengthening. - Conduct ecosystem assessments using WHO tools - Facilitate stakeholder consultations and validation workshops - Develop costed national/regional roadmaps - Support country profiling and regional manufacturing mapping 3. GMP/PQS/DATA INTEGRITY/WHO PQ TRAINING EXPERTS (7+ YEARS) Strengthen manufacturing quality systems, WHO PQ readiness, and regulatory inspection capacity through training and technical assistance. - Deliver training on GMP/cGMP, QMS/PQS, QRM, CAPA, data integrity, validation, utilities, QC labs - Support manufacturers preparing for GMP inspections or WHO PQ - Support NRAs in GMP inspection capacity building - Support TT programmes The deliverables below will be engagement specific and contractually time bound per consultant: - Regulatory policy and governance outputs - GMP inspection reports, SOPs, licensing tools - QMS/PQS tools and dossier assessment reports - Laboratory assessments and accreditation plans - Digital strategies and AI application reports - Ecosystem assessments and costed roadmaps - TT readiness assessments and TRL 4-7 technology identification - Regional manufacturing & R&D mapping - TA coordination matrices, partner alignment reports, mission planning outputs - Mission reports, stakeholder engagement outputs, monthly technical briefs 3. QUALIFICATIONS, EXPERIENCE, SKILLS AND LANGUAGES Educational Qualifications - Essential: Minimum a Master's degree in pharmacy, medicine, law, regulatory affairs, public health, biomedical engineering, IT, or related field. - Desirable: Advanced degree or a PhD in pharmacy, medicine, law, regulatory affairs, public health, biomedical engineering, IT, or related field. - Category A & B technical specialists: 7+ years. - Senior coordination experts: 10+ years. - Strong analytical, facilitation, and report writing skills. - Knowledge of WHO quality assurance standards. - Ability to work with governments, NRAs, manufacturers, and partners. - Excellent communication and stakeholder engagement skills. Languages and level required - Expert knowledge of English. - Working knowledge of French or Portuguese desirable 4. TECHNICAL SUPERVISION - WHO AFRO (HSS Cluster, MDI Unit). - Technical guidance from WHO HQ (PAM/PDM and RPQ/RSS). Off site: Home based but may be required to travel to Member States as required. If travel is required, this shall be pre-authorized by the WHO AFR/HSS/MDI Unit Team Lead and AFR/HSS Director and PSA / per diem payable in accordance with WHO policies. - Technical Specialists:Band level BUSD 7,000USD 9,980 per month - Senior Coordination Experts: Band level C: USD 10,00012,500 per month Three (3) months minimum 9. ADDITIONAL INFORMATION: - This vacancy notice may be used to identify candidates for other similar consultancies at the same level. - Only candidates under serious consideration will be contacted. - A written test may be used as a form of screening. - If your candidature is retained for interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution