Coordinator (Regulation of Medicines and other Health Technologies)

OBJECTIVES OF THE PROGRAMME

The Regulation of Medicines and other Health Technologies unit (RHT) 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. RHT works within the Access to Medicines, Vaccines and Pharmaceuticals (MVP) cluster departments in the wider framework of Universal Health Coverage and category 4 of the General 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 Sustainable Development Goals. The department works with a wide range of UN organizations, international partners and expert networks, and WHO Collaborating Centres.The objective of the Regulatory Systems Strengthening team is to provide guidance and technical support to develop, strengthen and sustain regulatory systems, authorities and networks to assure the quality, safety and efficacy of health technologies (medicines, vaccines, diagnostics and devices).

DESCRIPTION OF DUTIES

1. Lead the Regulatory Systems strengthening team, including planning, directing, monitoring the work and its human and financial resources in relation to the objectives of the program.

2. Lead and coordinate development of and advocacy for global strategies to strengthen regulatory systems, functions and networks, and serve as the Organization's focal point for National and Regional Regulatory capacity (management system).

3. Guide, support and supervise the development, maintenance and improvement of methods, including regulatory system assessment tools, indicators, and guidance, as well as a system for designating and maintaining WHO-listed authorities.

4. Guide and supervise benchmarking and technical support aimed at strengthening National Regulatory Authorities' (NRAs) capacity, e.g. the development of road maps, Institutional Development Plans (IDPs), training packages and/or plans of action as well as model strategies and other tools including to support supervision of sustainable local production of safe, efficacious and quality medical products/health technologies.

5. Lead and coordinate the provision of technical assistance and laboratory services in support of and in collaboration with the Prequalification Team.

6. Lead, manage and supervise - in collaboration with the Prequalification Team - activities to support NRAs to accelerate access to health technologies, including\:

 (a) collaborative procedures and joint assessments for registration of prequalified products in user countries;

(b) establishment of confidentiality/collaboration arrangements with NRAs to foster information sharing, in particular with regards to prequalified products;

(c) establishment of appropriate regulatory pathways and good regulatory practices.

7. Lead and coordinate a global network to facilitate greater coordination between the various partners and stakeholders working to provide support to regulatory systems strengthening and local production activities in WHO regions and countries.

 

8. Oversee the certification scheme on the quality of health technologies moving in international commerce.

 

9. Lead and facilitate international regulatory cooperation, convergence and harmonization, and coordinate efforts to enhance inter-country, regional and interregional collaboration, regional and regulatory networks. Coordinate organizational support to the International Conference of Drug Regulatory Authorities (ICDRA).

 

10. Oversee communication, resource mobilization and advocacy activities related to Regulatory Systems Strengthening.

 

11. Prepare appropriate reporting, including to the WHO governing bodies, on the above mentioned areas of work.

 

12. Undertake any other duties as required within field of competence, and as requested by the Head of the RHT unit.

REQUIRED QUALIFICATIONS

Education

Essential\: Advanced university degree (Masters level) in pharmacy, medicine, biology, biochemistry, chemistry, microbiology, or related health science.
Desirable\: PhD or specialization in the production or regulation of medical products.

Experience

Essential\: At least 15 years' experience working in the regulation of medical products, including at least five years of relevant experience at senior international level. At least seven years' experience in regulatory cooperation activities at the regional or international level, including harmonization and work-sharing initiatives. Experience in the implementation and management of collaborative projects at national and international/regional levels. Relevant experience working with low and middle income countries.
Desirable\: Extensive UN experience at regional and global level. Experience in writing project proposals and successful fundraising. Experience in working with health products' manufacturers and regulatory authorities in low and middle income countries.

Skills

Expertise in the regulation of health technologies and good understanding of WHO's policies and strategies in this area. Recognized leadership and ability to work with experts and networks at national, regional and international levels. Demonstrated ability to establish and maintain effective working relationships with people of different national and cultural background; and to supervise programmes, budgets, individuals and teams.

WHO Competencies

Teamwork
Respecting and promoting individual and cultural differences
Communication
Driving the Organization's Position in Health Leadership
Building and promoting partnerships across the organization and beyond
Creating an empowering and motivating environment

Use of Language Skills

Essential\: Expert knowledge of English.
Desirable\: Intermediate knowledge of French.

REMUNERATION

WHO salaries for staff in the Professional category are calculated in US dollars. The remuneration for the above position comprises an annual base salary starting at USD 97,805 (subject to mandatory deductions for pension contributions and health insurance, as applicable), a variable post adjustment, which reflects the cost of living in a particular duty station, and currently amounts to USD 5705 per month for the duty station indicated above. Other benefits include 30 days of annual leave, allowances for dependent family members, home leave, and an education grant for dependent children.

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 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.

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

• For information on WHO's operations please visit\: http\://www.who.int.

• WHO is committed to workforce diversity.

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

• WHO has a mobility policy which can be found at the following link\: http\://www.who.int/employment/en/. 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.

• Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.