Overview
Support Member States and regional networks in activities related to facilitated product introduction mechanisms through reliance, specifically the Collaborative Registration Procedure (CRP). The role also involves supporting Member States in building capacity for marketing authorization functions and assessment of applications according to WHO and international standards.
Key Responsibilities
- Support the national regulatory authorities in the region with the implementation of reliance and WHO Collaborative Registration Procedure (CRP), including through SEARN and ASEAN.
- Reply to technical questions regarding evaluation or GMP status of products and liaise with WHO HQ.
- Facilitate and support WHO HQ Special Access Programme for training and guidance.
- Support CRP participating NRAs in development, revision and updating policies, regulations, guidelines and tools for facilitated product introduction pathways and CRP implementation.
- Support the development and maintenance of the SEARN reliance database.
- Support the development and implementation of regional worksharing/convergence marketing authorization activities.
- Support the coordination and project management of related SEARN groups.
- Follow-up CRP submissions for countries in the region and assist NRAs with questions.
- Ensure the day-to-day running of CRP with national regulatory authorities in the region.
- Check and confirm with NRAs if they want to use CRP for specific applications.
- Follow-up CRP timelines for applications in the region and help collect metrics and statistics.
- Keep the electronic prequalification system (ePQS) up to date for CRP submissions and support publication of CRP metrics and information.
- Inform WHO HQ of any challenges or difficulties requiring additional support for CRP implementation.
- Support country reach out for CRP in the region.
- Arrange for regular advocacy to countries not currently participating in all WHO CRP pathways.
- Facilitate and support WHO HQ Special Access Programme for dedicated country or region advocacy workshops on reliance and CRP.
- Support the integration of regional worksharing activities with CRP and the development of the SEARN preparedness strategy.
- Provide technical support for dedicated regional joint assessment (e.g. ASEAN) or joint activities, especially through SEARN.
- 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.
- Support national regulatory authorities in the region to build capacity for the marketing authorization function and for assessment of marketing authorization.
- Support the establishment, maintenance and development of activities of WHO Collaborating Centres in the Region and SEARN Regional centers of excellence.
- Perform any other relevant duties assigned by supervisors.
- Deliver comprehensive, timely, client and solution-oriented technical and administrative support.
- Deliver 6 month Progress report.
- Deliver 9 month Progress report.
- Deliver Summary activity report.
Required Experience
- Five to ten years of relevant professional experience of working in the area of regulation of medical products.
- Acquired by working in an NRA or other relevant institution or working with medical products manufacturing industry and having significant experience in regulation and extensive engagement with NRAs.
- At least five years of experience in marketing authorization regulatory function.
- Proven ability to communicate and work in diverse cultural settings, to edit regulatory documents, and to contribute to achieving agreements among different stakeholders on regulatory matters for medical products.
- Experience in organizing, facilitating and conducting meetings, workshops, trainings, or other regulatory capacity building activities.
- Experience in preparing written reports, communication materials, and other documents (in English).
- Significant experience in GMP/GCP inspections (Desirable).
- Significant experience in South-East Asia (Desirable).
Qualifications
Advanced university degree (master’s level or above) in the area of pharmaceuticals/pharmacology, or a related field.
