Consultant - Country Regulatory System Strengthening And Cooperation

The purpose of this consultancy is to provide assistance in strengthening the Regulatory Systems for medical products of Member States in the Western Pacific Region and to support sustained regulatory management, particularly in the preparedness for any future pandemics.

The World Health Assembly (WHA) resolution number 67.20, 2014 emphasizes the role of World Health Organization (WHO) in strengthening Regulatory Systems for medical products from a public health perspective, and in supporting national regulatory authorities and relevant regional and international networks in this area. Essential Medicines and Health Technologies Unit (EMT), Division of Health Systems and Services (DHS), Western Pacific Regional Office (WPRO), continues to support the strengthening of the Regulatory Systems in the Western Pacific Region (WPR). Despite significant progress, many countries are still struggling to implement critical regulatory functions to the minimum level required by the World Health Assembly resolution WHA67.20 (2014). Low- and middle-income countries (LMICs) in the region that rely largely on the importation of medicines and vaccines to meet growing public health demand are at greater risk for a lack of access to quality-assured medicines and health technologies.

Strengthening Regulatory Systems requires a wide range of knowledge and technical expertise in various regulatory functions. Most countries have limited resources to exert all regulatory functions, therefore strategies and approaches need to be resource-considerate and practical. Recent approaches include the promotion of regulatory cooperation, convergence, and harmonization to address regulatory capacity gaps between countries and the introduction of a global benchmarking process to streamline strengthening activities.

The work of this consultancy contributes to the evaluation of national Regulatory Systems, application of WHO evaluation tools, evidence generation and analysis of Regulatory System performance, facilitating the formulation and implementation of institutional development plans and​ providing technical support to national regulatory authorities and governments.​

Estimated start date: 15 February 2024

Duration: 10.5 months (Offsite 8.5 months; onsite 2 months)

Under the supervision and guidance of the Medical Officer, RSS, EMT, DHS at the WHO Regional Office for the Western Pacific Region, the consultant will conduct desktop research, draft guidance documents and meeting reports, conduct in-country trainings and communicate with the national regulatory authorities (NRAs) and other stakeholders to deliver the following by the end of the contract period:

· Deliverable 1.1: Logistics and operations of the 13th Western Pacific Regional Alliance meeting of the national regulatory authorities with program agenda, discussion papers, speaker
nominations, and communications with speakers and participants

· Deliverable 1.2: Presentations for technical agendas, draft summary (within 2 weeks from the meeting) and full (within 3 months from the meeting) meeting reports

· Deliverable 2.1: Update of country-specific benchmarking roadmap and its progress including pre-visit, self-benchmarking report, verification of the report, updated institutional
development plan, and terms of reference for the benchmarking mission.
· Deliverable 2.2: Progress report of technical support for the implementation of the institutional development plans of the priority countries defined in Output 2

· Deliverable 3.1: Update of clinical research of medical countermeasures and new technologies against public health emergencies

· Deliverable 3.2: Report of country progress in planning and implementation of medical countermeasures and new technologies for preparedness for future pandemics

Essential: University degree in Medicine, Pharmacy, Chemistry or Biologicals or health-related sciences

Desirable: Post-graduate (master’s level) degree in Public Health (or related field)

Required: Minimum of five years of proven professional and working experience in clinical research or the regulation of medical products

Desirable: Experience on benchmarking of national regulatory authorities in developing countries

· Proven ability to plan and implement new strategies and activities to achieve a goal. Ability to function and communicate effectively. Broad knowledge of the regulation of medical products (e.g., review of product dossiers for quality, safety, and efficacy, pharmacovigilance, clinical trials, regulatory inspections, laboratory access and lot release, and market surveillance) is desirable.

· Ability to work effectively with national regulatory authority experts and stakeholders.

Essential: Fluent in English (writing, reading and speaking)

· Teamwork

· Respecting and promoting differences

· Communication

· Knowing and managing yourself

· Producing results

The consultant will work off-site.

The Consultant is expected to travel:

Travel dates: 5 June 2024 – 11 August 2024

Location: Manila, Philippines

Purpose: To assist in the preparation of the 13th Regional Alliance of NRAs meeting

All travel arrangements will be made by WHO – WHO will not be responsible for tickets purchased by the Consultant without the express, prior authorization of WHO. While on mission under the terms of this consultancy, the Consultant will receive subsistence allowance.

Visas requirements: it is the consultant’s responsibility to fulfil visa requirements and ask for visa support letter(s) if needed.

Additional Information

This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
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