Consultant – Regulatory Systems Strengthening at World Health Organization

Purpose of consultancy

The consultant will collaborate with the Regulatory Systems Strengthening (RSS) team focusing on capacity building of targeted countries’ national regulatory authorities (NRAs) through continuation of the maintenance and enhancement of the WHO Listed Authorities (WLA) framework, assessment of prioritized regulatory systems to identify strengths and gaps, development of institutional development plans (IDP) to build upon the identified strengths and address the gaps.  

The consultant will also contribute to training and capacity building activities in targeted countries in the areas of Good Regulatory Practices (GRP), Good Manufacturing Practices (GMP), Good Storage and Distribution Practices (GSDP) as well as WHO global benchmarking policy, methodology and tool.

Deliverables: 

Deliverable 1 - finalization and operationalization of the WLA framework: 

• Update the operational guidance (OpG) and manual for performance evaluation of regulatory authorities seeking designation as a WHO listed authority.
• Contribute to operationalization of the WLA framework including publication of updated list of WLA.
• Contribute to planning, organization and conduct of WLA remote as well as onsite assessments for the purpose of designation of WLA.

Deliverable 2 - development of training materials on WHO Good Regulatory Practices (GRP) guidelines: 

• Contribute to the design and development of the training course and its curriculum covering all sections of the WHO GRP guideline. This includes interviewing internal and external experts to get their views before completing the design of the course.
• Develop learning objectives and expected outcomes for the overall training programme as well as each individual module that should include purpose, scope and objective of the guideline as well as main principles, enablers and Regulatory Impact Assessment.
• Develop content and instructional designs, as well as other materials, for a hands-on face to face training that can be converted later to an online training.
• Convert the training contents into storyboard format, prepare it for digitalization and convert the training course into an online training.

Deliverable 3 - benchmarking and other related activities: 

• Facilitate the enhancement of the WHO Global Benchmarking Tool (GBT) including relevant manuals and procedures for benchmarking. 
• Contribute to the organization and conduct of two face to face trainings for GBT assessors. The consultant will also contribute to the digitalization of the applicable modules of the mentioned training.
• Contribute to the conduct of NRA benchmarking of regulatory systems in two to four priority countries as part of the WHO regulatory systems strengthening programme including technical guidance to complete self-benchmarking and/or verification when needed. 
• Contribute to the complementary benchmarking activities including observed audit.
• Follow up and provide technical guidance in the implementation of Institutional Development Plans (IDPs) elaborated following benchmarking of regulatory systems in two to four priority Member States.
• Contribute to the enhancement of electronic and automated solutions related to benchmarking including computerized GBT (cGBT), IDP follow up system, assessors database and others. 

Deliverable 4 - training and other capacity building activities: 

• Contribute to the planning, organization and conduct of training activities (e.g., GMP and GSDP training workshops) within the context of IDP implementation in targeted countries. 
• Contribute to the update of the relevant training materials whenever necessary.

Qualifications, experience, skills and languages.

Educational Qualifications:

Essential:

• Advanced university degree in pharmacy, chemistry, biology or other related field.

Desirable: 

• Studies in regulation of medical products.

Experience

Essential:

• Over 10 years of relevant experience working in the area of regulation of essential medicines and other health technologies acquired by working at national or regional regulatory authorities or pharmaceutical/biological manufacturer or other relevant institution.  
• Experience in development and delivery of highly technical training curriculum. 
• Demonstrated experience in an international context.

Desirable: 

• At least 5 years of relevant experience in regulatory inspection processes.

Skills

• Advanced knowledge of the WHO regulatory strengthening five-step capacity building model, the WHO NRA benchmarking tool along with the associated IDP elaboration.
• Advanced knowledge of the ongoing WHO Listed Authorities (WLA) initiative including different performance evaluation indicators and tools.
• Good knowledge of quality management principles and good practices (e.g. GRP, GMP, GSDP).
• Good skills in developing training curricula through collaboration and consultations with other team members.
• Effective in organizing, facilitating and conducting country visits, workshops, trainings, and other regulatory capacity building activities.
• Advanced ability to prepare written reports, terms of reference, and other documents (in English).
• Excellent ability to communicate and work in diverse cultural settings.
• Computer proficiency beyond the basics, particularly office environment (Excel, Word, PowerPoint).
• Knowledge of web-based collaborative platform: SharePoint and other databases.

Closing Date : Jan 3, 2023