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Purpose of consultancy
Under the supervision of the Unit Head, Medical Products Regulation, and in close collaboration with WHO headquarters (HQ REG SAP Lead), and country offices, the Consultant (Collaborative Registration Procedure) will Support Member States and regional networks, especially the South-East Asia Regulatory Network (SEARN) and the ASEAN joint assessment, in activities related to facilitated product introduction mechanisms though reliance, in particular the Collaborative Registration Procedure (CRP) and support Member States to build capacity of the marketing authorization function and assessment of marketing authorization applications according to WHO and international standards.
Background
National regulatory authorities (NRAs) are mandated to protect and promote public health by ensuring the timely availability of safe, effective, and quality medical products in line with international standards. WHO promotes information and work-sharing arrangements based on this principle of collaboration and reliance on the work products of trusted authorities and institutions to inform regulatory decision-making.
Deliverables
Deliverable 1: Attendance in induction meeting.
Deliverable 2: Activity plan agreed within the first month with Unit Head and HQ counterpart covering the following deliverables:
1. Support the national regulatory authorities in the region with the implementation of reliance and WHO Collaborative Registration Procedure including through the South-East Asia Regulatory Network (SEARN) and ASEAN:
- Provide technical support to countries for an efficient implementation of reliance mechanisms and WHO Collaborative Registration Procedure.
- Reply to requests from the national regulatory authority regarding any technical questions on the evaluation or the good manufacturing practices status for a specific product and liaise with WHO HQ, as necessary.
- Facilitate and support the WHO HQ Special Access Programme for training and any needed guidance for countries.
- To support CRP participating NRAs in development, revision and updating policies, regulations, guidelines and tools to support facilitated product introduction pathways and CRP implementation, in collaboration with WHO HQ.
- Support the development and maintenance of the SEARN reliance database
- Support the development and implementation of regional worksharing/convergence marketing authorization activities, including through SEARN
- Support the coordination and project management of the related SEARN groups.
- Follow-up CRP submissions for the countries in the region and help NRAs with any questions
- Ensure the day to day running of CRP with the national regulatory authority in the region.
- For each application, check and confirm with the national regulatory authority if they want to use CRP for this specific application.
- Follow-up CRP timelines for application in the region. Help in collecting metrics and statistics of CRP in the region.
- Keep the electronic prequalification system (ePQS) up to date for the CRP submissions in the region and support publication of CRP metrics and information.
- Inform WHO HQ of any challenges or difficulties requiring additional support for CRP implementation.
2. Support country reach out for CRP in the region
- In collaboration with WHO HQ and the relevant country office, arrange for regular advocacy to countries not currently participating in all WHO CRP pathways.
- Facilitate and support the WHO HQ Special Access Programme for dedicated country or region advocacy workshops on reliance and CRP.
- Support the integration of regional worksharing activities with the CRP and the development of the SEARN preparedness strategy to ensure timely access to medical countermeasures.
3. Support to regional joint assessment and joint activities
- Provide technical support, in collaboration with WHO HQ, 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.
4. Support to Global Health Products Procedures and involvement of NRA 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 for involvement of experts from the national regulatory authorities in the region.
5. Support the national regulatory authorities in the region to build capacity for the marketing authorization function and for assessment of marketing authorization
- In accordance with the regulatory system strengthening programme from WHO HQ, the WHO Global Benchmarking Tool and the potential developed Institutional Development Plans, support national regulatory authorities in the region to develop and strengthen the marketing authorization function and build capacity for assessment of marketing authorization applications in accordance with international standards.
- In collaboration with WHO HQ, support the establishment, maintenance and development of activities of WHO Collaborating Centres in the Region and SEARN Regional centers of excellence, including through assisting centers in developing curriculum, training material and coordinating the required expertise to support the marketing authorization function, including abridged reviews and product verification by NRAs participating in CRP and other facilitated pathways.
6. Other tasks:
- To perform any other relevant duties assigned by supervisors.
- Deliver comprehensive, timely, client and solution-oriented technical and administrative support across all budget centers, proactively strengthening country office capacity through responsive engagement, collaboration, and accountability to deliver measurable results for Member States.
Deliverable 3: 6 month Progress report agreed with Unit Head and HQ counterpart
Deliverable 4: 9 month Progress report agreed with Unit Head and HQ counterpart
Deliverable 5: Summary activity report agreed with Unit Head and HQ counterpart
Qualifications, experience, skills and languages
Educational Qualifications:
Essential: Advanced university degree (master’s level or above) in the area of pharmaceuticals/pharmacology, or a related field.
Experience
Essential:
- Five to ten years of relevant professional experience of working in the area of regulation of medical products and 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.
- A 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).
Desirable:
- Significant experience in GMP/GCP inspections
- Significant experience in South-East Asia
Skills/Knowledge:
Essential:
- Proven ability to handle projects.
- Experience required in preparing written reports, communication materials and other documents (in English).
- Good organizational skills.
- Computer proficiency beyond the basics, particularly office environment (Excel, Word, PowerPoint).
- Proven familiarity with regulatory facilitated pathways and mechanisms, including WHO Collaborative Registration Procedures (CRP) and/or novel regulatory pathways.
Languages and level required (Basic/Intermediate/Expert):
Essential: Expert knowledge of English
Desirable: Expert knowledge of South-East Asian language(s).
Location
On site: SEARO, New Delhi
Travel
As required by the activities as agreed by Unit Head and Director.
Remuneration and budget (travel costs are excluded):
Pay Band Level B - USD 77,000 (depending on the experience and the nature of work)
Living expenses - Travel expenses and per diem will be covered as per WHO rules applicable to consultants for approved official travel during the contract period.
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.
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