Senior Officer, Regulatory Affairs

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, we’re committed to creating an environment for you to thrive both personally and professionally.

The Team

The 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: “All 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.” 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. 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 foundation’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 AMA’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 Foundation’s AMA support strategy.

ii) Working with the foundation’s Global regulatory systems Deputy Director, support the foundation’s significant partnership with the WHO and its regional offices, and the foundation’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 WHO’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 You’ll Do

• Manage, develop, and help drive a portfolio of high-impact, complex grants and contracts requiring project development and management skills, as well as high-level strategy and interpersonal skills. Responsibilities include:

  Manage a complex network of implementing partners / grantees, for example by conducting site visits, providing technical guidance, convening meetings of key stakeholders, and applying and evaluating performance objectives.

  Review letters of inquiry and grant proposals; provide recommendations for funding including drafting and editing proposal summaries for submission to the Deputy Director, Director, President, Chief Executive Officer, and Chair.

  Partner with grantees to develop projects and define key outcomes and milestones. Ensure appropriate monitoring and evaluation systems and processes are established to produce robust evaluation of performance against milestones and outcomes.

  Collaborate with program and functional team members to manage internal processes, portfolio progress, documentation, and grant budget information and reporting.

  Serve as a point of contact on portfolio-related issues for key internal and external stakeholders.

• Represent the foundation to key program-related external constituencies and, as appropriate, on committees related to area of expertise and responsibilities of the position. This could include both formal and informal presentations such as making speeches, attending conferences and other meetings, as necessary.
• Write and produce informative briefings and other materials on role relevant key issues for Global Health team members and foundation leadership.
• This role is responsible for high quality interactions and clear and consistent communications with grantees and partners in the field.
• Travel will be predominantly in Europe, Africa, and the United States, and in other locations, as needed.  Ability to travel around 35% expected.
• Work within a team of equally dedicated and senior regulatory experts responsible for the various regulatory bodies of work who are in the US and Africa.

Your Experience

• Advanced degree required with demonstrated experience or equivalent.
  • MD, PhD, or LLM/JD (or equivalent)– with significant expertise after degree preferred
  • Deep expertise in Regulatory Affairs or in a national/regional medical products Regulatory Agency involving vaccines, biologics, drugs, and/or devices/diagnostics.  Experience working within the EMA and the European regulatory system preferred; experience working within WHO or a WHO-related institution preferred; experience with both highly preferred.
  • French language conversational competency, in addition to English, preferred. 
• Can communicate intricate regulatory and science concepts and nuances to partners with a diverse set of backgrounds, including senior leadership, program staff, grantees, and other foundation operational resources.
• Experience developing and implementing regulatory projects in Europe and Africa strongly preferred.
• Strong problem solving and strategy development experience.
• Demonstrated excellent project leadership, analytical, interpersonal, and written and oral communication skills, in positions requiring communication of data and results with a diverse audience of international stakeholders.
• Experience in pharmaceutical regulatory affairs (preferably in a regulatory agency), from research and clinical development to post-authorization and life-cycle management (including marketing authorizations) for vaccines, medicines, diagnostics, and/or vector control products, preferred.
• Demonstrated record of accomplishment of working collaboratively in a team-oriented, highly demanding environment with strong organizational and communications skills, at multiple levels of an organization. Self-motivated and self-managing.
• Experience in the conception, design and management of strategies, initiatives and programs including experience in managing complex projects and processes, from workplan development to implementation.
• Project management skills, organization skills, and relationship management skills necessary to work daily with the regulatory experts in any of our partner systems to help them implement.
• Demonstrated ability to work flexibly and effectively within a geographically dispersed and time-zone diverse team.  

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Hiring Requirements

As part of our standard hiring process for new employees, employment will be contingent upon successful completion of a background check.

Candidate Accommodations

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Inclusion Statement

We are dedicated to the belief that all lives have equal value. We strive for a global and cultural workplace that supports ever greater diversity, equity, and inclusion — of voices, ideas, and approaches — and we support this diversity through all our employment practices.

All applicants and employees who are drawn to serve our mission will enjoy equality of opportunity and fair treatment without regard to race, color, age, religion, pregnancy, sex, sexual orientation, disability, gender identity, gender expression, national origin, genetic information, veteran status, marital status, and prior protected activity.