Gates Foundation
Senior Program Officer, Regulatory Affairs (*2-Year LTE)
Gates Foundation, Seattle, Washington, us, 98127
Senior Program Officer, Regulatory Affairs (*2-Year LTE)
2-Year limited-term position with opportunities to contribute to regulatory affairs across global health initiatives.
Overview The Global Health Division seeks to harness advances and innovations in science and technology to save lives in developing countries. Integrated Development (IDEV) supports teams in Global Health, Global Development, and Gender Equality Divisions, with expertise in Regulatory, CMC, Quantitative Sciences, and Clinical Trials design. This role sits within the regulatory domain and partners with organizations including the World Health Organization (WHO) and European regulatory authorities to strengthen regulatory systems, with a focus on Africa and European regulatory collaboration.
Your Role You will report to the Deputy Director, Regulatory, Integrated Development, and may work remotely in the United Kingdom or Belgium. You are a problem solver, trusted business partner, and subject matter expert in regulatory affairs, especially European regulatory affairs and international regulatory systems.
Responsibilities
Manage, develop, and drive a portfolio of grants and contracts requiring project development, management, strategy, and stakeholder engagement. This includes overseeing a network of implementing partners/grantees, site visits, technical guidance, stakeholder meetings, and performance evaluation.
Review letters of inquiry and grant proposals; draft and edit proposal summaries for senior leadership submission; recommend funding decisions.
Partner with grantees to develop projects, define outcomes and milestones, and establish monitoring and evaluation systems to assess performance against milestones.
Collaborate with program and functional teams to manage processes, portfolio progress, documentation, and grant budgets and reporting.
Serve as a primary contact for portfolio-related issues with internal and external stakeholders.
Represent the foundation to external constituencies and participate in committees, conferences, and meetings as appropriate.
Prepare briefings and materials on key regulatory issues for Global Health team members and foundation leadership.
Travel predominantly in Europe, Africa, the United States, and other locations as needed; travel approximately 35% expected.
What You’ll Do (Specific Projects)
Support the establishment of an agile African Medicines Agency (AMA) through collaboration with AMA Secretariat and WHO leadership; help develop and track AMA support strategies.
Support the foundation’s partnerships with WHO and European regulatory authorities (e.g., EMA) and contribute to the development and execution of global regulatory strategies and grant programs.
Your Experience
Advanced degree required (e.g., MD, PhD, LLM/JD or equivalent); significant post-degree expertise preferred.
Deep expertise in Regulatory Affairs involving vaccines, biologics, drugs, devices/diagnostics; experience with EMA and WHO preferred.
French language conversational competency in addition to English preferred.
Ability to communicate complex regulatory and scientific concepts to diverse audiences, including senior leadership and international stakeholders.
Experience developing regulatory projects in Europe and Africa; strong project leadership and written/oral communication skills.
Experience in pharmaceutical regulatory affairs from research to post-authorization and life-cycle management; preferred.
Demonstrated ability to work in a fast-paced, team-based, international environment; self-motivated and self-managing.
Experience designing and managing complex initiatives from workplan to implementation.
Other Attributes
Strong problem solving and strategy development experience.
Project management, organizational, and relationship management skills to work with regulatory experts across partner systems.
Ability to work effectively across geographically dispersed teams.
Salary range: 186,400 to 288,800 USD. Regional adjustments may apply for Seattle and Washington, DC offices.
Hiring Requirements Employment is contingent upon successful completion of a background check.
Inclusion and Accommodations We are committed to diversity, equity, and inclusion in our workplace. If you require assistance due to a disability in the application or recruitment process, please submit a request.
Note All applicants and employees are treated with equality of opportunity regardless of race, color, age, religion, pregnancy, sex, sexual orientation, disability, gender identity, gender expression, national origin, or veteran status.
#J-18808-Ljbffr
Overview The Global Health Division seeks to harness advances and innovations in science and technology to save lives in developing countries. Integrated Development (IDEV) supports teams in Global Health, Global Development, and Gender Equality Divisions, with expertise in Regulatory, CMC, Quantitative Sciences, and Clinical Trials design. This role sits within the regulatory domain and partners with organizations including the World Health Organization (WHO) and European regulatory authorities to strengthen regulatory systems, with a focus on Africa and European regulatory collaboration.
Your Role You will report to the Deputy Director, Regulatory, Integrated Development, and may work remotely in the United Kingdom or Belgium. You are a problem solver, trusted business partner, and subject matter expert in regulatory affairs, especially European regulatory affairs and international regulatory systems.
Responsibilities
Manage, develop, and drive a portfolio of grants and contracts requiring project development, management, strategy, and stakeholder engagement. This includes overseeing a network of implementing partners/grantees, site visits, technical guidance, stakeholder meetings, and performance evaluation.
Review letters of inquiry and grant proposals; draft and edit proposal summaries for senior leadership submission; recommend funding decisions.
Partner with grantees to develop projects, define outcomes and milestones, and establish monitoring and evaluation systems to assess performance against milestones.
Collaborate with program and functional teams to manage processes, portfolio progress, documentation, and grant budgets and reporting.
Serve as a primary contact for portfolio-related issues with internal and external stakeholders.
Represent the foundation to external constituencies and participate in committees, conferences, and meetings as appropriate.
Prepare briefings and materials on key regulatory issues for Global Health team members and foundation leadership.
Travel predominantly in Europe, Africa, the United States, and other locations as needed; travel approximately 35% expected.
What You’ll Do (Specific Projects)
Support the establishment of an agile African Medicines Agency (AMA) through collaboration with AMA Secretariat and WHO leadership; help develop and track AMA support strategies.
Support the foundation’s partnerships with WHO and European regulatory authorities (e.g., EMA) and contribute to the development and execution of global regulatory strategies and grant programs.
Your Experience
Advanced degree required (e.g., MD, PhD, LLM/JD or equivalent); significant post-degree expertise preferred.
Deep expertise in Regulatory Affairs involving vaccines, biologics, drugs, devices/diagnostics; experience with EMA and WHO preferred.
French language conversational competency in addition to English preferred.
Ability to communicate complex regulatory and scientific concepts to diverse audiences, including senior leadership and international stakeholders.
Experience developing regulatory projects in Europe and Africa; strong project leadership and written/oral communication skills.
Experience in pharmaceutical regulatory affairs from research to post-authorization and life-cycle management; preferred.
Demonstrated ability to work in a fast-paced, team-based, international environment; self-motivated and self-managing.
Experience designing and managing complex initiatives from workplan to implementation.
Other Attributes
Strong problem solving and strategy development experience.
Project management, organizational, and relationship management skills to work with regulatory experts across partner systems.
Ability to work effectively across geographically dispersed teams.
Salary range: 186,400 to 288,800 USD. Regional adjustments may apply for Seattle and Washington, DC offices.
Hiring Requirements Employment is contingent upon successful completion of a background check.
Inclusion and Accommodations We are committed to diversity, equity, and inclusion in our workplace. If you require assistance due to a disability in the application or recruitment process, please submit a request.
Note All applicants and employees are treated with equality of opportunity regardless of race, color, age, religion, pregnancy, sex, sexual orientation, disability, gender identity, gender expression, national origin, or veteran status.
#J-18808-Ljbffr