Technical Officer - Collaborative Registration Procedure
Organizational Context
The World Health Organization (WHO) aims to promote health, ensure safety, and serve vulnerable populations globally. Its strategic priorities focus on achieving universal health coverage, addressing health emergencies, and promoting healthier populations across all age groups. This role supports Member States in enhancing their regulatory capacities through facilitated product introduction mechanisms, specifically the Collaborative Registration Procedure (CRP) and regulatory harmonization initiatives, ensuring adherence to international standards.
Job Purpose
The Technical Officer will support Member States in Rwanda and the region in implementing facilitated product introduction mechanisms, primarily 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 will facilitate regulatory harmonization initiatives, provide technical assistance to NRAs, and ensure the efficient day-to-day running of CRP processes. The incumbent will contribute to strengthening regulatory systems, enabling faster access to essential health products while maintaining quality and safety standards, and ultimately supporting the WHO's mission of promoting healthier populations.
Responsibilities
Under WHO supervision, the volunteer will provide technical support to National Regulatory Authorities (NRAs) in implementing reliance and the WHO Collaborative Registration Procedure (CRP), liaising with WHO HQ for technical queries and guidance. This includes assisting NRAs in developing and updating regulatory policies and tools. The role involves managing the day-to-day operations of CRP, tracking submission timelines, collecting metrics, and maintaining the electronic prequalification system (ePQS). Furthermore, the volunteer will support outreach to new countries for CRP participation, facilitate advocacy workshops, and provide technical support for regional joint assessments and global health product procedures. Capacity building for NRAs in marketing authorization and application assessment, in line with WHO standards and tools, is a key responsibility. The role also requires coordinating technical experts to ensure effective activity implementation.
Work Experience
A minimum of seven years of professional experience in medical product regulation is required, preferably within a National Regulatory Authority (NRA), pharmaceutical manufacturer, or similar institution. At least five years of this experience must be in the marketing authorization regulatory function. Familiarity with facilitated regulatory pathways, particularly WHO CRP, is essential. Experience in organizing capacity-building activities and preparing regulatory documents is also required.
Skills
The role requires strong teamwork, communication, and organizational skills, with the ability to produce results and ensure efficient resource use. Proficiency in working across diverse cultural settings, editing regulatory documents, and facilitating stakeholder agreement is crucial. Advanced computer skills, particularly in MS Office Suite (Excel, Word, PowerPoint), are necessary. Expertise in Pharmacy and allied health professions is expected.