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Roster of Consultants - Regulatory Systems Strengthening, Local Production Ecosystem Support, Technology Transfer & Technical Assistance Coordination
Full job description
Position details
- Vacancy number: 2603444
- Contractual arrangement: External consultant
- Contract duration: The consultancy contract duration varies from 1 to 11 months, depending on the need.
- Organization: AF/HSS Health Systems and Services
- Schedule: Full-time
- Closing date: Sep 22, 2026, 10:59:00 PM
1. BACKGROUND
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)
Summary Role:
Strengthen national regulatory policy, legislation, governance, and institutional frameworks. Support harmonization, reliance, and regulatory coherence.
Key Functions:
• 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)
Summary Role:
Improve regulatory oversight of manufacturing sites through GMP inspections, licensing system strengthening, and manufacturer readiness support.
Key Functions:
• 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)
Summary Role:
Strengthen regulatory quality systems and improve dossier assessment processes for medicines, vaccines, diagnostics, and medical devices.
Key Functions:
• 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)
Summary Role:
Enhance national QC laboratory capacity, accreditation readiness, testing methodologies, and data governance.
Key Functions:
• 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)
Summary Role:
Support digital transformation of regulatory systems through workflow digitalization, data governance, and AI enabled regulatory analytics.
Key Functions:
• 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)
Summary Role:
Provide strategic leadership and coordination of technical assistance for local production, ecosystem strengthening, technology transfer, and regional manufacturing development.
Key Functions:
• 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)
Summary Role:
Conduct ecosystem assessments and develop sequenced, costed national or regional roadmaps for manufacturing ecosystem strengthening.
Key Functions:
• 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)
Summary Role:
Strengthen manufacturing quality systems, WHO PQ readiness, and regulatory inspection capacity through training and technical assistance.
Key Functions:
• 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
2. DELIVERABLES
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.
Experience
• Category A & B technical specialists: 7+ years.
• Senior coordination experts: 10+ years.
Skills/Knowledge
• 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).
5. LOCATION
Off site: Home based but may be required to travel to Member States as required.
6. TRAVEL
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.
7. REMUNERATION
• Technical Specialists: Band level B - USD 7,000 - USD 9,980 per month
• Senior Coordination Experts: Band level C: USD 10,000 - 12,500 per month
8. CONTRACT DURATION
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 accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/ . Some professional certificates may not appear in the WHED and will require individual review.
• For information on WHO's operations please visit: http://www.who.int .
• WHO is committed to workforce diversity.
• WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
• Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
• WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter into practice.
• WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of final candidates.
• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. The execution of the work under a consultant contract does not create an employer/employee relationship between WHO and the Consultant.
• WHO shall have no responsibility whatsoever for any taxes, duties, social security contributions or other contributions payable by the Consultant. The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
• Consultants working in Switzerland must register with the applicable Swiss cantonal tax authorities and social security authorities, within the prescribed timeframes (Guidelines issued by the Swiss Mission are available at: https://www.eda.admin.ch/missions/mission-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html
For roster VNs:
The purpose of this vacancy is to develop a list of qualified candidates for inclusion in this advertised roster. All applicants will be notified in writing of the outcome of their application (whether successful or unsuccessful) upon conclusion of the selection process. Successful candidates will be placed on the roster and subsequently may be selected for consultancy assignments falling in this area of work or for similar requirements/tasks/deliverables. Inclusion in the Roster does not guarantee selection to a consultant contract. There is no commitment on either side.
Listing sourced from WHO careers. Applications are handled entirely by the employer.