National Programme Officer (Regulation and Prequalification)

OBJECTIVES OF THE PROGRAMME

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.

DESCRIPTION OF DUTIES

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.

REQUIRED QUALIFICATIONS

Education

Essential: University degree in medicine, pharmaceutical sciences, biochemistry, biotechnology, bioengineering, biomedical studies or other similar disciplines.
Desirable: Postgraduate degree in the above mentioned areas.

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/.

Experience

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.

Skills

• 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.

WHO Competencies

Enhanced WHO Global Competency Model: who-enhanced-competence.pdf

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

Use of Language Skills

Essential: Fluency in written and oral English and Mandarin.

REMUNERATION

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.

ADDITIONAL INFORMATION

• This vacancy notice may be used to fill other similar positions at the same grade level

• Only candidates under serious consideration will be contacted.

• A written test and/or an asynchronous video assessment may be used as a form of screening.

• In the event that your candidature is retained for an 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.

• According to article 101, paragraph 3, of the Charter of the United Nations, the paramount consideration in the employment of the staff is the necessity of securing the highest standards of efficiency, competence, and integrity. Due regard will be paid to the importance of recruiting the staff on as wide a geographical basis as possible.

• Any appointment/extension of appointment is subject to WHO Staff Regulations, Staff Rules and Manual.

• The Director-General retains the discretion to not make any appointment to this vacancy, to make an appointment at a lower grade, or to make an appointment with a modified job description, including shortening the duration of the appointment.

• WHO is committed to creating a diverse and inclusive environment of mutual respect. WHO recruits and employs staff regardless of disability status, sex, gender identity, sexual orientation, language, race, marital status, religious, cultural, ethnic and socio-economic backgrounds, or any other personal characteristics.

• WHO is committed to achieving gender parity and geographical diversity in its staff. Women, persons with disabilities, and nationals of unrepresented and underrepresented Member States (https://www.who.int/careers/diversity-equity-and-inclusion) are strongly encouraged to apply.

• Persons with disabilities may request reasonable accommodations (modifications or adjustments to the application or recruitment process) to support their participation in the application and recruitment process. Please send an email to reasonableaccommodation@who.int with your full name, the vacancy number you are applying for, and specific details of the accommodation needed in your request.

• An impeccable record for integrity and professional ethical standards is essential. WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter into practice.

• WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of final candidates.

• WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.

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• WHO also offers wide range of benefits to staff, including parental leave and attractive flexible work arrangements to help promote a healthy work-life balance and to allow all staff members to express and develop their talents fully.

• The statutory retirement age for staff appointments is 65 years. For external applicants, only those who are expected to complete the term of appointment will normally be considered.

• Please note that WHO's contracts are conditional on members of the workforce confirming that they are vaccinated as required by WHO before undertaking a WHO assignment, except where a medical condition does not allow such vaccination, as certified by the WHO Staff Health and Wellbeing Services (SHW). The successful candidate will be asked to provide relevant evidence related to this condition. A copy of the updated vaccination card must be shared with WHO medical service in the medical clearance process. Please note that certain countries require proof of specific vaccinations for entry or exit. For example, official proof /certification of yellow fever vaccination is required to enter many countries. Country-specific vaccine recommendations can be found on the WHO international travel and Staff Health and Wellbeing website. For vaccination-related queries please directly contact SHW directly at shws@who.int.

• This is a National Professional Officer position. Therefore, only applications from nationals of the country where the duty station is located will be accepted. Applicants who are not nationals of this country will not be considered.

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