CONSULTANT-SENIOR REGULATORY REVIEWER (AVAREF CLINICAL TRIAL PILOT)

Position details

• Vacancy number: 2604137
• Contractual arrangement: External consultant
• Contract duration: 2 months
• Organization: AF/DPC Health Promotion, Disease Prevention and Control
• Schedule: Full-time
• Closing date: Nov 13, 2026, 12:59:00 AM

IMPORTANT NOTICE: Please note that the deadline for receipt of applications indicated above reflects your personal device's system settings.

1.    Background and Justification

Access to innovative, affordable, safe, and effective medicines, vaccines, and health technologies of assured quality is key to enhancing Africa’s disease-fighting capacities, pandemic readiness, prevention, control, elimination, and eradication of the high communicable and non-communicable disease burden.

Research and development (R&D) and manufacturing capacity for these health products in Africa continues to be very low, leaving the tremendous economic and health benefits unlocked. Among the reasons for the low participation in R&D of medicines and vaccines are weak regulatory systems for oversight of clinical development and registration, inadequately resourced clinical trial sites, unwillingness of product developers and sponsors to bring clinical trials to Africa due to fewer experts, poor governance and lack of transparency, and prolonged timelines for evaluation of clinical trial applications by both National Ethics Committees (NECs) and National Regulatory Authorities (NRAs), and the fragmented regulatory systems in the 55 member states including approvals.

AVAREF, AdVancing ClinicAl TRials Excellence in AFrica, is a network of NRAs and NECs established 19 years ago by the WHO with its primary mission for capacity building of the NRAs and NECs. AVAREF is leveraging its strong network of NRAs and NECs and associated platform to enhance vaccine research and development. The AVAREF Secretariat situated within Vaccine Research and Innovation Unit (VRUI) within the Vaccine Preventable Diseases (VPD) Program is responsible for delivering on the workplan for a wide range of activities including capacity building initiatives, technical assistance to member states, and coordination of programs with partners and stakeholders.

To effectively address long standing irritants and bottlenecks for timely regulatory and ethic oversight of clinical trials in Africa, AVAREF initiated the Clinical Trial Pilot project following the Advisory Committee meeting in Dakar (September 2024), with 16 member countries selected based on the number of clinical trials, regional representation, regulatory maturity levels, and readiness to participate in this new phase of reliance-based regulatory collaboration. These member states nominated 3 reviewers each, a total of 48 expert reviewers across clinical, non-clinical, and quality domains, to be part of the pool of reviewers to form the basis of the reliance network; benefit from continuing education from preparatory workshops and seminars to be held over the 2 year period; hold meetings to map and harmonize regulatory frameworks; identify national gaps and opportunities for harmonization towards the establishment consistent frameworks for clinical trial oversight. It is an ambitious initiative designed to align regulatory and ethical review systems across the continent. Throughout the 2-year pilot, a digital platform for CTA submissions, harmonized SOPs, and coordinated review protocols would be developed and/or perfected. It is anticipated that the pool of reviewers would be a resource for CTA reviews to ensure high quality and timely decisions. The project requires expert support staff who are experienced regulatory scientists and reviewers with extensive experience from world class regulatory agencies (ML-4) agencies.

The ecosystem within which AVAREF operates require a Secretariat supported by highly competent professionals who are motivated, skilled with the right competencies, expertise, and experience to facilitate the delivery of results. As part of the program of work, AVAREF Secretariat is responsible for the developing the pool of reviewers within the network to support the goal of attracting clinical trials to the continent.

2.    Deliverables

The Consultant Senior Regulatory Reviewer – AVAREF Clinical Trial Pilot (Clinical) will work closely with the Coordinator, AVAREF Secretariat, the staff within the Secretariat, member states, especially the 48 reviewers from the 16 countries in the AVAREF clinical trial pilot project as a coach, mentor, and second reviewer to support their development within the 2-year pilot period.

AVAREF Clinical Trial Pilot Project
The AVAREF CT pilot is a major initiative for AVAREF as it implements its 2024-26 Strategic Plan and a foundation for its re-positioning in the current dynamic environment. The 16-member country initiative is an alternative model for provision of clinical trial oversight for Africa as well as lever for the ecosystem and life cycle approach. Given that the pool of reviewers will need coaching and mentorship as they develop the necessary skills for the evaluation of CTAs and other functions, it is imperative that this is provided by an experienced clinical trial evaluator with solid experience.

Support for Multi-country Joint Reviews, Scientific Advice, and Facilitated Registration
The AVAREF Secretariat supports member states by providing a platform for multi-country joint reviews, scientific advice for clinical trials as well as facilitated registrations for emergency use authorizations of medicines for public health. This function requires expert support and advice, specifically for the nominated reviewers as the process integrates capacity strengthening. The consultant will therefore provide the expert support needed for this critical and landmark function.

Reviewer Capacity Strengthening Initiatives
AVAREF’s core function includes capacity building and strengthening to NRAs and NECs. Initiatives such as the training of reviewers through various workshops and/or direct country support. Further the Consultant can support AVAREF modernization efforts including updating the guidelines, tool, and procedures to support harmonization and standardization.

Specifically, the Consultant will perform the following tasks:
• Provide training, mentorship, and coaching for the evaluation of clinical trial applications, especially the clinical component of the dossiers to the pool of reviewers within the clinical sub-group.
• Support the development of updated guidelines, SOPs, and checklists used for the review of clinical trial applications, specifically the clinical component.
• Support the ongoing multi-country joint reviews, scientific advice, and facilitated registrations for clinical trials and emergency use authorizations.
• Develop and deliver training workshops such as comprehensive clinical trial application review and writing assessment reports.
• Other related functions as determined by the AVAREF Coordinator.

Expected Outputs
• A report on the coaching and mentorship provided to the Reviewers of the AVAREF Clinical Trial Pilot program.
• A report for participation in the AVAREF multi-country joint reviews and scientific advice for clinical trials as well as facilitated registrations.
• Facilitating AVAREF workshops as required.

3.    Qualifications, experience, skills and languages

Identify the educational qualifications and expertise needed for the terms of reference outlined above.

Educational Qualifications

Essential: Doctorate in Medicine, Biomedical Sciences, Health Sciences; or Advanced university degree (Masters or higher) in a health-related field (medicine or health).

Desirable:
Advanced degree in medicine / public health / communicable/non-communicable diseases.
Non-clinical and safety specialization in review of clinical trial and/or registration dossiers. Toxicology, Pharmacology, Microbiology.
Advanced degrees in Biostatistics, Pharmacovigilance, or Pharmacoepidemiology.
Clinical specialization in Allergy and immunology, Anesthesiology, Cardiology, Dermatology, Diagnostic radiology, Emergency medicine, Family medicine, Internal medicine, Medical genetics, Neurology, Nuclear medicine, Obstetrics and gynecology, Ophthalmology, Oncology, Pathology, Pediatrics, Physical medicine and rehabilitation, Preventive medicine, Psychiatry, Radiation oncology, Surgery, or Urology.

Experience

Essential

Significant experience (at least 10 years) working in an internationally recognized national regulatory agency (ML-4).
Significant experience (at least 10 years) in aspects of regulation of medicines including vaccines, biotherapeutics, pharmaceuticals, advanced therapeutics, diagnostics.
Significant experience (at least 10 years) in the review of clinical trial dossiers, registration of new and/or existing medicines.
Significant experience (at least 10 years) in regulation of biotherapeutics, biosimilars, other biologics.

Desirable :
Demonstrated experience in medicines review and approval process in an internationally recognized national regulatory agency.

Expertise requirements:

Expertise in review of non-clinical and clinical data for vaccines and drug registration dossiers, Good Clinical Practice Inspection (GCP), Good Clinical Laboratory Practice (GCLP), Good Manufacturing Practice (GMP), Post Marketing Surveillance and monitoring, Biostatistics, Pharmacovigilance, or Pharmacoepidemiology.

Expertise in clinical specialties such as Allergy and immunology, Anesthesiology, Cardiology, Dermatology, Diagnostic radiology, Emergency medicine, Family medicine, Internal medicine, Medical genetics, Neurology, Nuclear medicine, Obstetrics and gynecology, Ophthalmology, Oncology, Pathology, Pediatrics, Physical medicine and rehabilitation, Preventive medicine, Psychiatry, Radiation oncology, Surgery, or Urology.

Minimum of 10 years of experience in an internationally recognized National Drug Regulatory Agency which has ML-4.

Experience in international agency, government, academia, industry, or research organizations with extensive analytical, deductive, and writing skills (publications in scientific journals).

Proven skills in communication and delivery of results.

Ability to work as a team under tight deadlines and work.

Experience working in Africa (or low- and middle-income countries) as well as in advanced economies.

Other Skills:
Excellent knowledge of data collection tools, Statistical packages, Communication packages and Microsoft application (e.g. Excel, Word, Power Point, etc.), xml.
Knowledge of project management software.

Languages and level required
Excellent knowledge of English and French and working knowledge of the other language will be an asset.

4.    Technical Supervision

The Incumbent will be supervised by the Technical Officer, Implementation Research Portfolio Coordinator, AVAREF Secretariat (WHO-AFRO).

5.    Location

Off-site (Home based).

6.     Remuneration and budget (travel costs excluded)

Band level B - USD 7,000 - 9980 per month.

7.     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.
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•    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.
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