Technical Officer (Regulatory Systems Strengthening)

Geneva | Geneva

OBJECTIVES OF THE PROGRAMME : The Department of Essential Medicines and Health Products (EMP) works with Member states and partners to improve the access to essential medicines and other health technologies of assured quality, safety and efficacy or effectiveness. The EMP department works with the HIS cluster departments in the wider framework of Universal Health Coverage and category 4 of the Global programme of Work, and cooperates with disease oriented programmes (among others HIV/AIDS, TB, malaria, reproductive health, maternal and child health, immunization, NCDs and mental health) towards the Millennium Development Goals. The department works with a wide range of UN organizations, international partners and expert networks, and WHO Collaborating Centres. The department has three large areas of work:(1) Regulation of Medicines and other Health Technologies (RHT) unit (covering medicines, vaccines, other biologicals, blood products, medical devices and diagnostics), which consists of four teams covering the normative and standard setting work, the prequalification of medicines, vaccines and diagnostics for UN and international procurement, the strengthening of regulatory systems and networks, and the safety and vigilance of health technologies. RHT is also responsible for work on detection and /counterfeit (SSFFC) medical products.(2) Policy, Access and Use team, which includes the Expert Committee of Selection and Use of Essential medicines, and the Expert Committee on Drug dependence, and covers the work on national policies, procurement, supply management and pricing of health technologies. (3) Public Health, Innovation and Intellectual Property team which covers the Global Strategy and Plan of Action on Public health, Innovation and Intellectual property, and works with countries on local production and transfer of technology approaches; and on strategies for management of intellectual property issues. The objective of the Regulatory Systems Strengthening Team (RSS) is to support all Member States to strengthen their capacity so that they will have regulatory systems to ensure that all medical products and other health technologies on their markets meet internationally recognized standards of quality, safety and efficacy. From this perspective RSS contributes to access to medical products of assured quality and to strengthen health systems in Member States.Purpose of the position:The post is required to assist Member States in strengthening regulatory systems for medical products and health technologies, including medical devices and diagnostics, particularly in low and middle-income countries. Description of duties: Organizational Context:The incumbent's work is guided by the resolutions of the World Health Assembly, and by WHO's Executive Board. Under the guidance of the Group Lead, Capacity Building and Harmonization Support the incumbent will:- Provide technical support to Member States National Regulatory Authorities (NRAs) in regulatory matters within the scope of adopted national work plans or upon requests by the respective Member States, in close collaboration with WHO Regional and Country Offices, other WHO departments involved in essential medicines and other health products, WHO Collaborating Centres, other reference centres and development partners.- Together with other members of RSS Team monitor and update the WHO global NRA databases and propose improvements to meet upcoming needs.- Collaborate with the NRA Assessment Group by providing routine feedback on the outcomes of assessments and by supporting the development and monitoring of Institutional Development Plans (IDPs).- As part of the development of WHO country support technical packages, select, compile and develop good practice tools, guidelines and training material for specific technical regulatory areas that will be adapted and used in countries. - Assist regional and subregional groups of countries for harmonization of regulatory requirements (including regulatory procedures and guidelines) for essential medicines and other health technologies, by providing technical advice and support.- Participate in the WHO NRA technical seminars, meetings and workshops and provide the necessary technical input as assigned by the First level Supervisor and as per WHO HQ, ROs or WCO demands.- Develop and edit scientific publications, progress reports, and technical presentations and documents and other reports related to NRA activities which help to advocate and raise awareness of the work being conducted by the Capacity Building and Harmonization Support Group. - Interact and collaborate with other technical programmes at WHO and outside the WHO that are instrumental to the success of this programme.- Undertake other tasks as required by Capacity Building and Harmonization Support Group Lead, RSS Coordinator and/or RHT Unit Head. REQUIRED QUALIFICATIONS Education: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: Some professional certificates may not appear in the WHED and these will be reviewed individually.Essential:A first university degree in pharmacy, medicine, biology, chemistry, biochemistry, engineering or related sciences.Desirable:Advanced university degree in regulatory affairs, public health, health technology, legislation, or related science.*For WHO staff please see e-manual III.4.1, para 220. Skills: Sound knowledge of pharmaceutical policy / regulations and of the essential medicines concept. Sound knowledge of development and implementation of harmonized regulatory procedures and guidelines within groups of countries.Knowledge of formulation of regulatory requirements for essential medicines and other health technologies, development of technical guidelines and standard operating procedures. Understanding of the importance of good regulatory practices guidelines/standards in the regulation of essential medicines and other health technologies. Knowledge of development of training material and training of regulatory personnel. Knowledge of development of indicators and tools for monitoring and evaluation of the performance of regulatory systems. Project management skills and good presentation, communication and writing skills. Ability to work in a team and to collaborate with other WHO departments, regional and country offices and partners, and to exercise sufficient flexibility to be effective in a multicultural environment.Competencies:1. Producing results2. Communicating in a credible and effective way3. Knowing and managing yourself4. Fostering integration and teamwork5. Respecting and promoting individual and cultural differences Experience: Essential:At least 5 years of professional experience working in the area of regulation of essential medicines and other health technologies acquired by working in NRA or pharmaceutical /biological manufacturer. Solid experience in the implementation of good regulatory practices in the area of medicines regulation. Experience in the implementation and management of collaborative projects in regulation for essential medicines and other health technologies at national and international/regional levels. Experience of working with WHO guidelines and other internationally recognized technical standards and norms.Desirable:Experience dealing with national legislation particularly in relation to public health related matters. Experience in one or more specific areas of the regulation of medical products, such as marketing authorization, licensing of facilities, testing, pharmacovigilance, oversight of clinical trials,etc. Field experience in strengthening or providing advice to national regulatory systems in low- and middle-income countries. Experience in WHO or in UN setting and/or other experience at the international level. Languages: Essential:Excellent knowledge of EnglishDesirable:Intermediate knowledge of French. Intermediate knowledge of another UN language. Additional Information: Please visit the following websites for detailed information on working with WHO: (to learn more about WHO's operations) Click on: Quick Links > Salary Scales > by dateWHO's salaries are calculated in US dollars. They consist of a base salary and a post adjustment, which reflects the cost of living in a particular duty station and exchange rates. Other benefits include: 30 days annual leave, family allowance, home travel, education grant for dependent children, pension plan and medical insurance. This vacancy is published in English only.Candidates appointed to an international post with WHO are subject to mobility and may be assigned to any activity or duty station of the Organization throughout the world. Post Adjustment: 88.8 % of the above figure(s). This percentage is to be considered as indicative since variations may occur each month either upwards or downwards due to currency exchange rate fluctuations or inflation. This vacancy notice may be used to fill other similar positions at the same grade level. A written test and interviews may be used as a form of screening Online applications are strongly encouraged to enable WHO to store your profile in a permanent database. Please visit WHO's e-Recruitment website at: The system provides instructions for online application procedures. All applicants are encouraged to apply online as soon as possible after the vacancy has been posted and well before the deadline stated in the vacancy announcement. WHO is committed to workforce diversity. Any appointment/extension of appointment is subject to WHO Staff Regulations, Staff Rules and Manual. Only candidates under serious consideration will be contacted. Currently accepting applications
Before applying, please make sure that you have read the requirements for the position and that you qualify.
Applications from non-qualifying applicants will most likely be discarded by the recruiting manager.
  • Organization: WHO - World Health Organization
  • Location: Geneva | Geneva
  • Grade: P-3, International Professional
  • Occupational Groups:
  • Closing Date: 2016-05-16

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