Technical Officer - Collaborative Registration Procedure

Organizational Context

The World Health Organization (WHO) aims to promote health, ensure global safety, and serve vulnerable populations with measurable impact. Its strategic priorities include achieving universal health coverage, addressing health emergencies, and promoting healthier populations for all ages. This role supports Member States in regulatory harmonization and capacity building for marketing authorization functions, utilizing facilitated product introduction mechanisms like the Collaborative Registration Procedure (CRP) and international standards.

Job Purpose

The incumbent will support Member States in implementing facilitated product introduction mechanisms, specifically the Collaborative Registration Procedure (CRP). This involves building the capacity of national regulatory authorities (NRAs) in marketing authorization functions and the assessment of applications according to WHO and international standards. The role contributes to regulatory harmonization initiatives, enabling efficient access to essential health products and strengthening the overall regulatory landscape within the region, ensuring compliance and quality.

Responsibilities

Under WHO supervision, the volunteer will support NRAs in implementing reliance and the WHO Collaborative Registration Procedure (CRP), liaising with WHO HQ for technical guidance and product evaluations. This includes assisting NRAs with CRP submissions, managing timelines, collecting metrics, and updating the electronic prequalification system (ePQS). The role involves outreach to new countries for CRP participation and facilitating advocacy workshops. Additionally, the volunteer will support regional joint assessments, global health product procedures (e.g., EU-M4all), and capacity building for marketing authorization functions, aligning with WHO's regulatory strengthening programs and the Global Benchmarking Tool. Coordination of technical experts is also a key responsibility.

Work Experience

Requires at least seven years of professional experience in medical product regulation, with a minimum of five years in marketing authorization. Experience with regulatory facilitated pathways, including WHO CRP, is essential. Demonstrated experience in organizing capacity-building activities and preparing reports in English is also necessary. Familiarity with global health matters and diverse cultural settings is beneficial.

Skills

Key competencies include teamwork, communication, results production, and efficient resource utilization, alongside respecting and promoting individual and cultural differences. Technical expertise in pharmacy and allied health professions is required. Proficiency in office software (Excel, Word, PowerPoint) and strong organizational skills are essential for project handling and stakeholder engagement.

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