Bill & Melinda Gates Foundation
Senior Program Officer, Regulatory Affairs Product Support ( •2-Year LTE)
Bill & Melinda Gates Foundation, Seattle, Washington, us, 98127
Overview
The Foundation is the largest nonprofit fighting poverty, disease, and inequity around the world. We aim for a world where people everywhere have the chance to live healthy, productive lives. We emphasize diversity and provide an exceptional benefits package including 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. We are committed to creating an environment for you to thrive both personally and professionally. The Team
The Global Health Division harnesses science and technology to save lives in developing countries. We work with partners to deliver proven tools and diagnostics and to discover affordable, reliable new solutions. Integrated Development (IDEV) is a cross-functional team within the Global Health Division that also supports teams in Global Development and Gender Equality Divisions. IDEV provides expertise in Regulatory, Chemistry Manufacturing and Controls (CMC), and Global Health Integrated Development Expertise (GHIDE), 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 guides global regulatory strategies, addresses complex questions, and ensures filing strategies are designed and executed to accelerate registration and access—particularly in LMICs. The product scope includes medicines (NCEs and generics), biologics, vaccines, IVDs, medical devices (including AI-enabled and SaMD), live biotherapeutics, gene therapies, and evolving product types. 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 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 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 discovery to delivery of products in the Foundation’s portfolio. Ensure we have fit-for-purpose SMEs to advise on regulatory issues and strategies for each product. Work with the Deputy Director of Regulatory Strategy and Product Support to drive development and execution of innovative and efficient regulatory strategies that align with the Foundation’s goals to accelerate access of GH products in LMICs, including WHO Prequalification where necessary. Provide grantees with support on strategy, tactics and external resources (CROs, consultants) 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; travel is predominantly in Europe, Africa, and the United States, with additional locations as needed. Ability to travel around 15% expected. Your Experience Advanced degree with 10+ years of Industry or Regulator experience or 20+ years of industry experience. Deep experience with product development, regulatory strategy, registration and regulatory life-cycle management, preferably with LMIC experience. Some experience with products targeting global infectious diseases including pharmacology/pharmacokinetics/immunology is preferable. Strong knowledge of FDA, EMA, and WHO PQ regulatory processes; experience with other regulatory authorities (EU, Canada, Australia, India, China, South Africa) is preferred. Experience with WHO Prequalification and Facilitated Regulatory Pathways is highly preferred. Ability to communicate intricate regulatory concepts to PSTs and grantees with diverse backgrounds, including senior leadership, program staff, grantees, and other foundation resources. Experience in health product regulatory affairs from research and clinical development to post-authorization and life-cycle management (including marketing authorizations) required. Proven ability to work collaboratively in a team-oriented, demanding environment with strong organizational and communications skills at multiple levels. Self-motivated and self-managing. Experience in conceiving, designing, and managing strategies, initiatives, and programs, including managing complex projects from workplan development to implementation. Other Attributes Strong problem-solving and strategy development experience. Excellent project leadership, analytical, interpersonal, and written and oral communication skills. Project management, organization, and relationship management skills to work daily with regulatory experts in partner systems to help them implement. Ability to work flexibly within a geographically dispersed and time-zone diverse team. Salary 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. New hires salaries are typically between the range minimum and the salary range midpoint. Actual placement will depend on job-related skills, experience, and expertise, as evaluated during the interview process. 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.
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The Foundation is the largest nonprofit fighting poverty, disease, and inequity around the world. We aim for a world where people everywhere have the chance to live healthy, productive lives. We emphasize diversity and provide an exceptional benefits package including 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. We are committed to creating an environment for you to thrive both personally and professionally. The Team
The Global Health Division harnesses science and technology to save lives in developing countries. We work with partners to deliver proven tools and diagnostics and to discover affordable, reliable new solutions. Integrated Development (IDEV) is a cross-functional team within the Global Health Division that also supports teams in Global Development and Gender Equality Divisions. IDEV provides expertise in Regulatory, Chemistry Manufacturing and Controls (CMC), and Global Health Integrated Development Expertise (GHIDE), 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 guides global regulatory strategies, addresses complex questions, and ensures filing strategies are designed and executed to accelerate registration and access—particularly in LMICs. The product scope includes medicines (NCEs and generics), biologics, vaccines, IVDs, medical devices (including AI-enabled and SaMD), live biotherapeutics, gene therapies, and evolving product types. 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 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 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 discovery to delivery of products in the Foundation’s portfolio. Ensure we have fit-for-purpose SMEs to advise on regulatory issues and strategies for each product. Work with the Deputy Director of Regulatory Strategy and Product Support to drive development and execution of innovative and efficient regulatory strategies that align with the Foundation’s goals to accelerate access of GH products in LMICs, including WHO Prequalification where necessary. Provide grantees with support on strategy, tactics and external resources (CROs, consultants) 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; travel is predominantly in Europe, Africa, and the United States, with additional locations as needed. Ability to travel around 15% expected. Your Experience Advanced degree with 10+ years of Industry or Regulator experience or 20+ years of industry experience. Deep experience with product development, regulatory strategy, registration and regulatory life-cycle management, preferably with LMIC experience. Some experience with products targeting global infectious diseases including pharmacology/pharmacokinetics/immunology is preferable. Strong knowledge of FDA, EMA, and WHO PQ regulatory processes; experience with other regulatory authorities (EU, Canada, Australia, India, China, South Africa) is preferred. Experience with WHO Prequalification and Facilitated Regulatory Pathways is highly preferred. Ability to communicate intricate regulatory concepts to PSTs and grantees with diverse backgrounds, including senior leadership, program staff, grantees, and other foundation resources. Experience in health product regulatory affairs from research and clinical development to post-authorization and life-cycle management (including marketing authorizations) required. Proven ability to work collaboratively in a team-oriented, demanding environment with strong organizational and communications skills at multiple levels. Self-motivated and self-managing. Experience in conceiving, designing, and managing strategies, initiatives, and programs, including managing complex projects from workplan development to implementation. Other Attributes Strong problem-solving and strategy development experience. Excellent project leadership, analytical, interpersonal, and written and oral communication skills. Project management, organization, and relationship management skills to work daily with regulatory experts in partner systems to help them implement. Ability to work flexibly within a geographically dispersed and time-zone diverse team. Salary 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. New hires salaries are typically between the range minimum and the salary range midpoint. Actual placement will depend on job-related skills, experience, and expertise, as evaluated during the interview process. 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.
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