The World Health Organization (WHO) plays a pivotal role in supporting countries in strengthening their regulatory systems, and promoting equitable access to quality, safe, efficacious, and affordable medical products and health products. In light of these WHO mandates, a Regulatory System Strengthening (RSS) programme has been established few decades ago. World Health Assembly resolution (WHA67.20) on regulatory system strengthening emphasized the WHO mandate and requested both WHO and Member States to invest more in this area and to address all health products and technologies.
The WHO Representative's Office, China provides technical support for prequalification of medical products and the Regulatory System Strengthening in the Chinese National Regulation Authority (the National Medical Products Administration, NMPA) for the regulation of medicines, vaccines and diagnostics. This collaboration has contributed to the efforts to strengthen regulatory systems in China for both domestic and global health benefits. In the current Country Cooperation Strategy, working with NMPA and other partners in RSS including vaccines and medical products Prequalification is one of the strategic priorities endorsed by both WHO and Government of China.
The incumbent will perform the following:
1. Provide technical advice/guidance to the China National Medical Products Administration (NMPA) and its affiliated institutions in planning and receiving the assessment for WHO-Listed Authorities (WLA) on vaccine regulation, based on the valid WHO Benchmarking with Global Benchmarking Tool (GBT) revision IV, as well as the indicators for Maturity Level 4, relevant indicators for Performance Evaluation (PE) and PE tools and follow up activities in China.
2. Provide technical assistance to the China NMPA and its affiliated institutions in planning and receiving the WHO Benchmarking on medicines and medical devices including in vitro diagnostics regulation with WHO Global Benchmarking Tool (GBT) updated revisions and follow-up activities in China. Also coordinate with Regional Office and Headquarters in the planning of these activities.
3. Provide technical support and serve as the focal person in the Country Office for WHO prequalification activities involving Chinese medical products, follow up and provide feedback regarding quality and/or pharmacovigilance issues identified for prequalified Chinese medical products, and support the carrying out of prequalification inspections on Chinese medical products.
4. Coordinate with WHO RSS to facilitate the implementation of the Institutional Development Plan (IDP) with NMPA and all relevant institutions in China, which are concluded from different WHO assessments to the Chinese National Regulatory Authority: the assessment for WLA in vaccine regulation, the GBT benchmarking for medicine and in-vitro diagnostics regulation, and maintain and provide routine feedback to the Regional Office and Headquarters.
5. Participate in, facilitate, support and/or manage WHO NRA technical seminars, workshops, and/or country training courses to provide specialist technical support to the National Medical Products Administration (NMPA) and its affiliated institutions, provincial drug authorities, in the area of regulatory function strengthening.
6. Participate in the WPR Regional Alliance for NRA activities (assessment, follow-up, capacity building, etc.) upon request of the Regional Office.
7. Expand and maintain the roster of Chinese regulatory experts, and coordinate with Headquarters and the Regional Office to include them in the relevant rosters. Monitor conflict of interest (COI) declaration of Chinese experts involved in WHO activities and report any issue.
8. Update NRA global/regional databases (doses of vaccines, medicines, medical devices including in vitro diagnostics, lot release, production, capacity building, country profile, NRA planning, good manufacturing practice (GMP) inspections, assessment/follow-up).
9. Update and organize reporting and feedback using the Regional Office and HQ SharePoint site consistent with Country Office, Regional Office and Headquarters policies, and keeping in mind confidentiality and conflict of interest issues. Work with relevant institutions, and/or the national teams involved to provide input.
10. Serve as the focal point in the Country Office for Substandard and Falsified medical products, coordinate communication between Headquarters/WPRO with NMPA.
11. Work as the focal point in the Country Office for regulatory preparedness.
12. Undertakes other related tasks as required by the country office.
Essential: University degree in medicine, pharmaceutical sciences, biochemistry, biotechnology, bioengineering, biomedical studies or other similar disciplines.
Desirable: Postgraduate degree in the above mentioned areas.
Essential: At least five years’ experience in medical products regulation programmes and activities such as registration and/or regulation of medical products.
Desirable:
• Experience in one or more specific areas such as marketing authorization, licensing, testing, pharmacovigilance, oversight of clinical trials, inspections on Good Manufacturing Practice, and quality assurance
• Experience in regulation of medical products from authority or industry aspects.
• Experience in a national or international institution leading or managing an equivalent area.
• Familiarity with WHO NRA assessment procedures including Benchmarking of regulatory systems with GBT and/or WHO-Listed Authorities assessment.
• Strong track record in collaborating with regulators and/or scientists from a national regulatory authority or national control laboratory, medical products industry.
• Experience in WHO or in UN setting and experience in strategic planning and project management are an asset.
• Knowledge of Chinese regulatory system for medical products, including the technical process and requirements for registration and regulation of medical products.
• Capacity to plan and conduct operational activities with political and technical elements.
• Ability to establish harmonious working relationships as part of a team, adapt to diverse educational and cultural backgrounds, and maintain a high standard of personal conduct.
• Ability to demonstrate gender equity and cultural appropriateness in the delivery of services to Member State/s.
1. Teamwork
2. Respecting & promoting individual and cultural differences
3. Communication
4. Producing results
5. Moving forward in a changing environment
6. Building and promoting partnerships across the organization and beyond
Essential: Fluency in written and oral English and Mandarin.
Remuneration comprises an annual base salary starting at CNY 804,630 (subject to mandatory deductions for pension contributions and health insurance, as applicable) and 30 days of annual leave.
In case the website does not display properly, please retry by:
(i) checking that you have the latest version of the browser installed (Chrome, Edge or Firefox);
(ii) clearing your browser history and opening the site in a new browser (not a new tab within the same browser); or
(iii) retry accessing the website using Mozilla Firefox browser or using another device. Click this link for detailed guidance on completing job applications: Instructions for candidatesInterested candidates are strongly encouraged to apply on-line. For assessment of your application, please ensure that
- your profile on Stellis is properly completed and updated;
- all required details regarding your qualifications, education and training are provided;
- all experience records are entered with elaboration on tasks performed at the time; and
- please note that CV/PHFs inserted via LinkedIn are not accessible.