Technical Officer (regulation And Prequalification)

Organizational Context

The Department of Regulation and Prequalification (RPQ) at WHO ensures the global quality, safety, and efficacy of medicines and health products. It focuses on building regulatory capacity in LMICs, establishing reliance mechanisms among National Regulatory Authorities, and streamlining prequalification processes to contribute to global health and sustainable development.

Job Purpose

This role coordinates the implementation of the antivenom risk-benefit assessment project, managing daily activities, overseeing dossier reviews by scientific panels, and coordinating external laboratory testing. It involves assessing manufacturing site compliance with GMP, analyzing data for evidence-based decision-making, and reporting to donors and management. The position also ensures data curation and manages partnerships, providing expert advice on snake antivenom regulation to Member States and regional offices.

Responsibilities

Coordinate the antivenom risk-benefit assessment project, including daily activity management, dossier review by a scientific panel, and establishing Technical Services Agreements with external laboratories for product testing. Assess manufacturing site compliance with WHO Good Manufacturing Practice (GMP). Analyze data from risk-benefit assessments to produce technical reports and support decision-making. Manage donor and internal reporting, ensuring data is curated in a standardized repository. Coordinate partnerships, such as with Wellcome Trust, and provide expert technical advice on snake antivenom production, control, and regulation to Member States and WHO regional offices.

Work Experience

Essential: At least 7 years of experience in biological standardization and/or the development, production, control, and quality assurance of vaccines and biologicals, with national and international experience. Desirable: Experience in snakebite antivenom development/manufacturing, quality control, and regulation; familiarity with WHO prequalification and NRA assessment procedures.

Skills

Essential knowledge of risk-based antivenom assessment procedures. Demonstrated experience in antivenom assessment and evaluation. Solid understanding of regulatory requirements for biological products. Good understanding of Good Manufacturing Practices (GMP) and relevant Quality Management Systems (QMS). Expert knowledge of English; desirable knowledge of French.

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