Consultant – Regulatory Systems Strengthening

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.

Background

The Regulation and Prequalification Department (RPQ) through the Regulation and Safety (REG) Unit works with Member States and partners to improve the access to essential medicines and other health technologies of assured quality, safety and efficacy or effectiveness. RPQ works within the Access to Medicines and Health Products Division (MHP) in the wider framework of Universal Health Coverage and category 4 of the General Programme of Work and cooperates with disease-oriented programmes (among others HIV/AIDS, TB, malaria, reproductive health, maternal and child health, immunization, NCDs and mental health) towards the Sustainable Development Goals. The department works with a wide range of UN organizations, international partners and expert networks, and WHO Collaborating Centres.

The objective of the RSS team is to support all Member States to strengthen their capacity so that they will have regulatory systems to ensure that all medical products and other health technologies are accessible, affordable and meet internationally recognized standards of quality, safety and efficacy. From this perspective, RSS contributes to facilitate access to medical products of assured quality and to strengthening regulatory systems, as part of the health system, in Member States.

Within the WHO RSS programme, and supported with multiple World Health Assembly (WHA) Resolutions, the RSS team is working on all country-specific regulatory system capacity building activities including evaluating national regulatory systems, developing and applying WHO benchmarking tools, generating and analyzing evidence of regulatory systems performance and facilitating the formulation and execution of institutional development plans (IDPs) as well as providing technical support to national regulatory authorities (NRA) in Member States. In addition, RSS team is working on full implementation of a framework for designating and publicly listing a regulatory authority as a WHO Listed Authority (WLA) responding to Member States requests to develop a transparent and evidence-based pathway for regulatory authorities operating at an advanced level of performance to be globally recognized, thereby replacing the procurement-oriented concept of stringent regulatory authorities.

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.

Languages required:

Essential:

• Expert knowledge of English.

Location

Off-site: Home based.

Travel

The consultant is expected to travel.

Remuneration and budget (travel costs are excluded):

Remuneration:

Band level C-USD 10,000 – 12,500 per month.

Living expenses (A living expense is payable to on-site consultants who are internationally recruited):

N/A

Expected duration of contract:

11 months.

Additional Information

• This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
• Only candidates under serious consideration will be contacted.
• A written test may be used as a form of screening.
• If your candidature is retained for interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
• For information on WHO's operations please visit: http://www.who.int.
• WHO is committed to workforce diversity.
• WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
• Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
• WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter into practice.
• WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of final candidates.
• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. The execution of the work under a consultant contract does not create an employer/employee relationship between WHO and the Consultant.
• WHO shall have no responsibility whatsoever for any taxes, duties, social security contributions or other contributions payable by the Consultant. The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
• Consultants working in Switzerland must register with the applicable Swiss cantonal tax authorities and social security authorities, within the prescribed timeframes (Guidelines issued by the Swiss Mission are available at: https://www.eda.admin.ch/missions/mission-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html