Senior Officer, Regulatory Affairs

Tags: Global Health English language Environment
  • Added Date: Monday, 05 May 2025
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The Foundation

We are the largest nonprofit fighting poverty, disease, and inequity around the world. Founded on a simple premise: people everywhere, regardless of identity or circumstances, should have the chance to live healthy, productive lives. We believe our employees should reflect the rich diversity of the global populations we aim to serve. We provide an exceptional benefits package to employees and their families which include comprehensive medical, dental, and vision coverage with no premiums, generous paid time off, paid family leave, foundation-paid retirement contribution, regional holidays, and opportunities to engage in several employee communities. As a workplace, weโ€™re committed to creating an environment for you to thrive both personally and professionally.

The TeamThe Global Health Division seeks to harness advances and innovations in science and technology to save lives in developing countries. We work with partners to deliver proven tools and diagnostics, as well as discover pathbreaking new solutions that are affordable and reliable.

Integrated Development (IDEV) is a cross functional team within the Global Health Division but also supports teams in Global Development and Gender Equality Divisions at the Gates Foundation. IDEV brings expertise in service to R&D and systems development in the four domains of Regulatory, Chemistry Manufacturing and Controls (CMC), Quantitative Sciences including pharmacology and big data, and Clinical Trials design and informativeness (DAC).

Within the regulatory domain sit several subdomains or Bodies of Work (BOW). Several of these bodies of work focus on strengthening regulatory systems. One such BOW focuses on global initiatives to strengthen regulatory systems. Our major partner within this BOW is the World Health Organization. Another BOW is one that focuses of non-Africa based regulatory systems strengthening initiatives, many of which involve partnerships with academic institutions, high income country regulatory authorities, and others to support our regulatory systems strengthening work in Africa, and that focus on initiatives in non-African geographies. Another BOW focuses exclusively on strengthening African regulatory systems throughout the African continental, regional, and national regulatory ecosystem. The vision of this BOW is: โ€œAll of Africa has access to quality essential medical products through strong Africa regulatory systems anchored on ML3/ML4/WLA agencies, RECs, AMA, reliance and innovation.โ€ The Africa Regulatory Systems Body of work (BOW), a partnership with the Africa Regional Office, was established at end of 2021.

Your Role

As a Senior Officer Regulatory, you will report to the Deputy Director, Regulatory, Integrated Development and should be able to work remotely in the United Kingdom or Belgium. You are creative, thoughtful, and a curious leader that identifies as a problem solver, trusted business partner, and subject matter expert in regulatory affairs, especially European regulatory affairs and international regulatory systems.

You would be responsible for managing and developing a portfolio of grants focusing on optimizing regulatory systems through which medical products (medicines, vaccines, and in vitro diagnostics) and vector control products must go to be and stay safely marketed and procured legally in Foundation focus countries (primarily low-income countries in sub-Saharan Africa). The role and responsibilities of the Senior Officer will be focused on two separate but related general portfolios of work:

i) Working with the foundationโ€™s Africa regulatory systems Deputy Director, support the establishment of an agile, efficient, and impactful African Medicines Agency (AMA) through thought-partnership with and advice to the AMA Secretariat; facilitate the AMAโ€™s exchange and experience sharing with the European Medicines Agency senior leadership, technical committees and working groups; and support the development, execution, and tracking of the Foundationโ€™s AMA support strategy.

ii) Working with the foundationโ€™s Global regulatory systems Deputy Director, support the foundationโ€™s significant partnership with the WHO and its regional offices, and the foundationโ€™s partnerships with other non-Africa based institutions, including the EMA and other European regulatory authorities; facilitate the development and implementation of grants and strategies with the WHOโ€™s divisions and departments involved with prequalification of medical products and with regulatory systems strengthening work within WHO member states, including meeting with and supporting WHO leaders in these areas up to the level of the Assistant Director General; support the development, execution, and tracking of the Foundations global regulatory systems strategies.

What Youโ€™ll Do

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