Overview
The Consultant will support Member States activities related to facilitated product introduction mechanisms, particularly the Collaborative Registration Procedure (CRP), and build capacity in marketing authorization functions and application assessments according to WHO and international standards.
Key Responsibilities
- Provide technical support to countries for implementation of reliance mechanisms and/or WHO Collaborative Registration Procedure.
- Reply to technical questions from national regulatory authorities regarding product evaluation or good manufacturing practices status and liaise with WHO HQ.
- Facilitate and support WHO HQ Special Access Programme for training and guidance for countries.
- Support NRAs in development, revision and updating of policies, regulations, guidelines and tools for facilitated product introduction pathways and CRP implementation.
- Follow-up CRP submissions for countries in the region and assist NRAs with questions for participating countries.
- Support the running of CRP for national regulatory authorities in the region.
- Check and confirm with national regulatory authorities if they want to use CRP for specific applications.
- Follow-up CRP timelines for applications in the region and support the collection of CRP metrics and statistics.
- Ensure electronic prequalification system (ePQS) for CRP submissions in the region is up to date and support publication of CRP metrics and information.
- Inform WHO HQ of any challenges or difficulties requiring additional support for CRP implementation.
- Support national regulatory authorities in the Region to develop and strengthen marketing authorization functions, including capacity building for assessment of marketing authorization applications, using the WHO Global Benchmarking Tool and agreed Institutional Development Plans.
- Support country outreach for CRP in the region for additional countries.
- Arrange outreach to new countries not currently participating in WHO CRP.
- Facilitate and support WHO HQ Special Access Programme for country or region advocacy workshops on reliance and CRP.
- Provide technical support for dedicated regional joint assessment or joint activities for any upcoming/ongoing procedure.
- Facilitate and support the use of the Joint Assessment Information Management System.
- Help in collecting metrics and statistics of joint assessment or joint activities in the region.
- Support activities for global health products procedures such as EU-M4all with the EMA or Swissmedic Marketing Authorisation for Global Health products.
Required Experience
- At least five years of professional experience in regulation of medical products, especially in marketing authorization, acquired by working in an NRA or a pharmaceutical/biological manufacturer or other relevant institutions.
- Proven familiarity with regulatory facilitated pathways and mechanisms, including WHO Collaborative Registration Procedures (CRP).
- Experience in facilitating and conducting meetings, workshops, trainings, or other regulatory capacity building activities.
- Experience in preparing technical reports.
- Experience with ASEAN joint assessments or unilateral reliance procedures would be an advantage.
Qualifications
- Essential: First university degree in pharmaceutical sciences, or related field.
- Desirable: Advanced university degree (master’s level or above) in the area of pharmaceuticals/ pharmacology, or a related field.
