CONSULTANT-SENIOR REGULATORY REVIEWER (AVAREF CLINICAL TRIAL PILOT)

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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.

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.

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.

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.

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

Off-site (Home based).

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

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