Dear Colleagues,
WHO is seeking experienced international consultants to support our Special Access Programme, Regulation and Safety Unit in Geneva to advance the work with Member States and other partners in improving access to essential quality assured medical products through implementation of facilitated regulatory reliance pathways and Collaborative Registration Procedures (CRP).
The regulatory approval of medical products in countries can be lengthy and unpredictable, which often compromises patients’ timely access to much-needed safe, effective, and quality-assured medicines, and this is often more prevalent in countries operating at low levels of regulatory capacity. There is significant experience of the use of reliance by regulatory authorities, as a principle, to improve the efficiency of their regulatory systems. Reliance allows an authority to leverage the scientific evaluation performed by other authorities to decide on medical products approval within their jurisdiction. This reduces duplication of regulatory efforts, resources, and time, while maintaining national sovereignty. WHO has facilitated Regional Joint Assessments and developed collaborative procedures to accelerate the assessment and approval of medical products by resource-limited authorities.
The WHO Special Access Programme (SAP) coordinates the implementation of WHO Collaborative Registration Procedures (CRP) as a tool allowing National Regulatory Authorities (NRAs) to have access to assessments and inspection reports of medical products, performed by reference authorities/institutions following stringent and international standards. The procedure supports in country marketing authorization and registration of WHO prequalified medicines and vaccines, in vitro diagnostics and vector control products and medical products authorized by WHO Listed Authorities. The Programme also supports other facilitated product introduction mechanisms such as regional Joint Assessments, global health products procedures (e.g. European Medicines Agency EU Medicines for all and Swissmedic Marketing Authorization for Global Health Products) and further provides capacity building of national registration systems in the Member States.
Consultant profile:
Essential:
- First university degree in pharmaceutical sciences, or related field. Advanced university degree (master’s level or above) in pharmaceutical sciences/pharmacology, or a related field.
- At least seven years of professional experience working in regulation of medical products acquired by working in an NRA or a pharmaceutical /biological manufacturer or other relevant institution such as Academia.
- At least seven years of regulatory experience in scientific assessment of product dossiers for marketing authorization of medicines and vaccines, in vitro diagnostics or vector control pro ducts.
Desirable:
- Proven experience of implementing facilitated reliance regulatory pathway and mechanisms at in an NRAs, including work sharing and Collaborative Registration Procedures (CRP).
- Experience in participation and implementation of regional harmonization initiatives, work sharing and joint assessments.
- Experience in organizing, facilitating, and conducting meetings, workshops, trainings, or other regulatory capacity-building activities.
- Experience in development and maintenance of product applications database and registration databases and publication in public domains
- Advanced experience in preparing written reports, communication materials, and other documents (in English).
Nature and objectives of the work to be performed:
Under the supervision of the Senior Technical Officer, Special Access Programme, consultants will undertake the following work;
- Assist in the management of new and existing submissions and registrations of medicines and vaccines, in vitro diagnostics or vector control products under the Collaborative Registration Procedures for WHO prequalified products and WLA approved medicines.
- Support in the provision of technical support in Regional Joint Assessment activities/initiatives, including product assessments and capacity building, support to global health products.
- Support and optimize the use of electronic prequalification system (PQS) platform for end-to-end implementation of CRP for medicines and vaccines, in vitro diagnostics or vector control products.
- Support in the organization of training, meetings, workshops, and other advocacy and technical support activities for NRAs, manufacturers and other stakeholders.
- Assist the programme in the development, maintenance and revision of Communication Materials and QMS documentation pertaining to CRP.
Contract dates: 6 months, starting in September 2026.
Location of work: This assignment is home based, with limited travel as when required.
Only selected candidates will be contacted (individually) by the WHO Secretariat.
Curriculum vitae should be submitted to WHO/RPQ/REG/SAP by electronic mail with the subject of “Call for consultant RPQ/REG/FPI/CRP” to the following contact:
- Marie Valentin. Senior Technical Officer, Special Access Programme: Email: valentinm@who.int
Cc: bacha@who.int
The deadline for applications is 20 July 2026.
Kind Regards,
…
Sunday KISOMA
Technical Officer
Regulation and Safety Unit
World Health Organization
WHO Headquarters, Geneva