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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, 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 the 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, big data, AI, and Clinical Trials design and informativeness (DAC).

We are seeking an exceptional Senior Program Officer (SPO) to join our Regulatory Strategy and Product Support domain. This domain supports the Foundation’s product development investments by guiding global regulatory strategies, addressing complex regulatory questions, and ensuring filing strategies are designed and executed to accelerate registration and access—particularly in low and middle income countries (LMICs). The work is delivered through IDEV’s Global Health Integrated Development Experts (GHIDE) program—a multidisciplinary team that provides world-class product development support to Foundation teams, grantees and partners. The product scope includes medicines (NCEs and generics), biologics, vaccines, IVDs, medical devices (including AI enabled and SaMD), live biotherapeutics, and product types based on evolving Foundation’s priorities and investments.

Your Role

As a Senior Program Officer, you will report to the Deputy Director of Regulatory Strategy and Product Support. You are a creative, thoughtful, and strategic leader who brings a problem-solving mindset and is recognized as a trusted partner and subject matter expert in regulatory affairs. Your expertise spans global regulatory filing strategies, WHO prequalification, and LMIC registration pathways for global health products. You will collaborate closely with experts in CMC, quantitative sciences, and clinical development to ensure that the Foundation’s product development investments are informed by high-quality technical input—driving sound, timely, and evidence-based decision-making.

*This position is a limited-term position for 2-Years

What You’ll Do

+ Provide internal PSTs with product specific regulatory support from the discovery to delivery of products in the Foundation’s portfolio. Given the wide range of products, it will be necessary for you to ensure we have fit for purpose SMEs to advise you and/or the PST on the regulatory issues and strategies for each product.

+ You will work closely with the Deputy Director of Regulatory Strategy and Product Support to help drive the development and execution of innovative and efficient regulatory strategies that align with the Foundation’s goals to accelerate access of GH products in LMICs. Importantly, this includes WHO Prequalification, where necessary.

+ Provide grantees with support on strategy, tactics and external resources (CROs, consultants) as needed to ensure timely trial initiation and product registrations

+ Advise PSTs and grantees on opportunities to leverage Facilitated Regulatory Pathways (e.g., EUMedicines4All, Swiss Medic MAGHP, PQ or WLA CRP).

+ Provide regulatory and strategic input into Target Product Profiles, Integrated Product Development Plans and regulatory engagement strategies.

+ Identify development risks and mitigation strategies from a regulatory perspective to increase the probability of regulatory success.

+ Travel may be necessary in be predominantly in Europe, Africa, and the United States, and in other locations, as needed. Ability to travel around 15% expected.

Your Experience

+ Advanced degree with 10+ years Industry or Regulator experience or 20+ years industry experience required.

+ Deep experience with product development, regulatory strategy, registration and regulatory life-cycle management ideally with some experience in LMICs. Some experience with products targeting global infectious diseases including pharmacology/pharmacokinetics/immunology is preferable. Strong knowledge of major industrialized country regulatory processes and considerations, FDA, EMA, and WHO PQ. Experience with other developed and developing nations (e.g. national regulatory authorities in the EU, Canada, Australia, India, China, and South Africa) is preferred.

+ Experience with the process and requirements for WHO Prequalification and Facilitated Regulatory Pathways highly preferred.

+ Can communicate intricate regulatory concepts and nuances to PSTs and grantees with a diverse set of backgrounds, including senior leadership, program staff, grantees, and other foundation operational resources.

+ Experience in health product regulatory affairs, from research and clinical development to post-authorization and life-cycle management (including marketing authorizations) required.

+ 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.

Other Attributes

+ Strong problem solving and strategy development experience.

+ Demonstrated excellent project leadership, analytical, interpersonal, and written and oral communication skills.

+ Project management skills, organization skills, and relationship management skills are 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.

The salary range for this role is $186,400 to $288,800. We recognize high-wage market differences in Seattle and Washington D.C., where our offices are located. The range for this role in these locations is $203,100 to $314,900 USD. As a mission-driven organization, we strive to balance competitive pay with our mission. New hires salaries are typically between the range minimum and the salary range midpoint. Actual placement in the range will depend on a candidate’s job-related skills, experience, and expertise, as evaluated during the interview process.

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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

If you require assistance due to a disability in the application or recruitment process, please submit a request here.

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.