International Consultant - Collaborative Registration Procedure

Organizational Context

The World Health Organization (WHO) works to ensure the timely availability of safe, effective, and quality medical products. National regulatory authorities are mandated to protect public health, and WHO promotes collaboration and work-sharing among trusted authorities to inform regulatory decision-making.

Job Purpose

This role supports Member States and regional networks, particularly the South-East Asia Regulatory Network (SEARN) and ASEAN joint assessment, in implementing facilitated product introduction mechanisms through reliance. The consultant will focus on the Collaborative Registration Procedure (CRP) and assist Member States in enhancing their marketing authorization functions and assessment capabilities to align with WHO and international standards. The objective is to improve regulatory efficiency and ensure access to essential medical products.

Responsibilities

Provide technical support to countries for the implementation of reliance mechanisms and the WHO Collaborative Registration Procedure (CRP). Respond to technical queries from national regulatory authorities regarding product evaluations and GMP status, liaising with WHO HQ as needed. Facilitate training and guidance for countries through the WHO HQ Special Access Programme. Support NRAs in developing and updating policies, regulations, and tools for facilitated product introduction pathways and CRP implementation. Maintain the SEARN reliance database and support regional worksharing activities. Coordinate and manage SEARN groups, follow up on CRP submissions, and collect relevant metrics and statistics. Ensure the day-to-day operation of CRP with regional NRAs, confirm CRP usage for specific applications, and keep the electronic prequalification system (ePQS) updated. Report any challenges in CRP implementation to WHO HQ.

Work Experience

Essential: 5-10 years of relevant professional experience in medical product regulation, either within an NRA or a related institution, or with the manufacturing industry with extensive engagement with NRAs. At least 5 years of experience in marketing authorization regulatory functions. Proven ability to work in diverse cultural settings, edit regulatory documents, and facilitate agreement among stakeholders. Experience in organizing and conducting meetings, workshops, and training. Experience in preparing written reports and communication materials in English. Desirable: Significant experience in GMP/GCP inspections and in South-East Asia.

Skills

Project management, report writing, communication, organizational skills, computer proficiency (Excel, Word, PowerPoint), familiarity with regulatory facilitated pathways and mechanisms (e.g., WHO CRP).

Explore related opportunities