Consultant Senior Regulatory Reviewer – AVAREF Clinical Trial Pilot

Job Posting Organization:
AVAREF, which stands for AdVancing ClinicAl TRials Excellence in AFrica, is a network of National Regulatory Authorities (NRAs) and National Ethics Committees (NECs) established 19 years ago by the World Health Organization (WHO). The primary mission of AVAREF is to build the capacity of NRAs and NECs across Africa. The organization operates within the Vaccine Research and Innovation Unit (VRUI) of the Vaccine Preventable Diseases (VPD) Program, focusing on enhancing vaccine research and development. AVAREF is committed to addressing the challenges faced in the regulatory oversight of clinical trials in Africa, particularly in improving the efficiency and effectiveness of the regulatory processes. The organization aims to create a robust ecosystem for clinical trials by leveraging its network to facilitate better governance, transparency, and timely evaluations of clinical trial applications. With a strong emphasis on capacity building, AVAREF is dedicated to ensuring that Africa can effectively participate in global health initiatives and improve health outcomes through better access to innovative health technologies.

Job Overview:
The Consultant Senior Regulatory Reviewer will play a crucial role in the AVAREF Clinical Trial Pilot project, which is a significant initiative aimed at enhancing clinical trial oversight in Africa. This position involves working closely with the Coordinator of the AVAREF Secretariat and the 48 reviewers from 16 member countries participating in the pilot project. The consultant will act as a coach and mentor, providing guidance and support to these reviewers as they develop their skills in evaluating clinical trial applications. The role is essential for ensuring that the reviewers are well-equipped to conduct high-quality assessments and make timely decisions regarding clinical trials. The consultant will also be involved in the development of updated guidelines and standard operating procedures (SOPs) for the review process, contributing to the overall goal of harmonizing regulatory frameworks across the continent. This position is integral to the successful implementation of AVAREF's 2024-26 Strategic Plan and aims to attract more clinical trials to Africa by strengthening the regulatory environment.

Duties and Responsibilities:
The Consultant Senior Regulatory Reviewer will be responsible for a variety of tasks, including:

• Providing training, mentorship, and coaching to the pool of reviewers within the clinical sub-group, focusing on the evaluation of clinical trial applications.
• Supporting the development of updated guidelines, SOPs, and checklists for the review of clinical trial applications, particularly the clinical components.
• Assisting in the ongoing multi-country joint reviews, scientific advice, and facilitated registrations for clinical trials and emergency use authorizations.
• Developing and delivering training workshops on comprehensive clinical trial application review and writing assessment reports.
• Preparing reports on the coaching and mentorship provided to the reviewers and participation in AVAREF multi-country joint reviews.
• Facilitating AVAREF workshops as required.
• Collaborating with the AVAREF Secretariat and member states to ensure effective communication and coordination throughout the pilot project.

Required Qualifications:
The position requires a Doctorate in Medicine, Biomedical Sciences, Health Sciences, or an advanced university degree (Masters or higher) in a health-related field. Desirable qualifications include an advanced degree in public health or specialization in communicable/non-communicable diseases, as well as expertise in non-clinical and safety review of clinical trial dossiers. Additional desirable qualifications include advanced degrees in Biostatistics, Pharmacovigilance, or Pharmacoepidemiology, and clinical specialization in various medical fields such as Allergy and Immunology, Cardiology, Dermatology, and others. The consultant should possess significant experience in regulatory aspects of medicines, including vaccines and biotherapeutics, and have a strong background in reviewing clinical trial dossiers.

Educational Background:
Essential educational qualifications include a Doctorate in Medicine, Biomedical Sciences, Health Sciences, or an advanced university degree in a health-related field. Desirable qualifications may include advanced degrees in public health, toxicology, pharmacology, microbiology, biostatistics, or clinical specialties. The educational background should reflect a strong foundation in health sciences relevant to the regulatory review of clinical trials.

Experience:
The position requires at least 10 years of significant experience working in an internationally recognized national regulatory agency (ML-4). This includes extensive experience in the regulation of medicines, vaccines, biotherapeutics, and the review of clinical trial dossiers. The consultant should have a proven track record in the approval process for medicines and experience in regulatory oversight in both advanced economies and low- and middle-income countries. Experience in providing expert support and advice in a multi-country context is also essential.

Languages:
Excellent knowledge of English and French is mandatory, with a working knowledge of other languages being an asset. The ability to communicate effectively in both languages is crucial for collaboration with diverse stakeholders across the AVAREF network.

Additional Notes:
This consultancy position is off-site (home-based) and offers a remuneration band level B, with a monthly salary ranging from USD 7,000 to 9,98

• The vacancy notice may also be used to identify candidates for other similar consultancies at the same level. Candidates under serious consideration will be contacted, and a written test may be used as part of the screening process. Applicants must provide scanned copies of their educational qualifications in advance if selected for an interview. WHO emphasizes workforce diversity and encourages applications from women and nationals of underrepresented Member States. The organization maintains a smoke-free environment and has a zero-tolerance policy towards sexual exploitation and abuse, ensuring a safe and respectful workplace.