National Professional Officer (Regulatory System Strengthening)

Job Posting Organization:
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. Established on April 7, 1948, WHO's mission is to promote health, keep the world safe, and serve vulnerable populations. With over 7,000 employees in more than 150 countries, WHO works globally to ensure that all people can attain the highest possible level of health. The organization operates in various countries, providing technical assistance and support to strengthen health systems, improve health outcomes, and respond to health emergencies. WHO's commitment to regulatory system strengthening is evident in its initiatives to enhance the capacity of national regulatory authorities and ensure the safety and efficacy of medical products.

Job Overview:
The National Professional Officer (Regulatory System Strengthening) position at WHO involves providing technical support and guidance to the China National Medical Products Administration (NMPA) and its affiliated institutions. The incumbent will be responsible for planning and facilitating WHO assessments related to vaccine regulation and medical products, ensuring compliance with WHO standards. This role requires collaboration with various stakeholders, including regional offices and headquarters, to implement the Institutional Development Plan (IDP) and support prequalification activities for Chinese medical products. The officer will also participate in training seminars and workshops to enhance the regulatory capabilities of NMPA and provincial drug authorities. The position is crucial for strengthening regulatory systems in China, contributing to both domestic and global health benefits.

Duties and Responsibilities:

• Provide technical advice and guidance to NMPA on vaccine regulation assessments based on WHO Benchmarking and Global Benchmarking Tool (GBT) indicators.
• Assist NMPA in planning and receiving WHO Benchmarking on medicines and medical devices regulation, coordinating with WHO Regional Office and Headquarters.
• Serve as the focal point for WHO prequalification activities, providing feedback on quality and pharmacovigilance issues for Chinese medical products.
• Facilitate the implementation of the IDP with NMPA and relevant institutions, maintaining communication with WHO offices.
• Organize and manage technical seminars and training courses for NMPA and provincial drug authorities.
• Participate in regional NRA activities as requested by the Regional Office.
• Maintain a roster of Chinese regulatory experts and monitor conflict of interest declarations.
• Update global/regional databases related to medical products and regulatory activities.
• Organize reporting and feedback processes in line with WHO policies. 1
• Act as the focal point for Substandard and Falsified medical products communication. 1
• Support regulatory preparedness initiatives. 1
• Undertake other related tasks as required by the country office.

Required Qualifications:
Essential qualifications include a university degree in medicine, pharmaceutical sciences, biochemistry, biotechnology, bioengineering, or biomedical studies. A postgraduate degree in these areas is desirable. Candidates must have at least five years of experience in medical products regulation programs, including registration and regulation activities. Desirable qualifications include experience in marketing authorization, licensing, pharmacovigilance, clinical trials oversight, and quality assurance. Familiarity with WHO assessment procedures and a strong track record of collaboration with regulatory authorities are also beneficial.

Educational Background:
Candidates must possess a university degree in relevant fields such as medicine, pharmaceutical sciences, or biomedical studies. A postgraduate degree is preferred. WHO only considers higher educational qualifications from accredited institutions recognized in the World Higher Education Database (WHED).

Experience:
The position requires a minimum of five years of relevant experience in medical products regulation, including activities related to registration and oversight of medical products. Experience in specific areas such as pharmacovigilance, clinical trials, and quality assurance is desirable. Familiarity with WHO assessment procedures and experience in a national or international institution is an asset.

Languages:
Fluency in written and oral English and Mandarin is essential for this position. Proficiency in additional languages may be considered an advantage.

Additional Notes:
This is a National Professional Officer position, and only applications from nationals of China will be accepted. The role offers an annual base salary starting at CNY 804,630, along with 30 days of annual leave. Candidates under serious consideration will be contacted, and a written test or video assessment may be part of the screening process. WHO is committed to diversity and inclusion, encouraging applications from women and underrepresented groups. The organization has a zero-tolerance policy towards sexual exploitation and abuse, and candidates must adhere to high ethical standards.