Jobs & Career
Senior Program Officer, Regulatory Affairs Product Support – $186,400 to $314,900 Annually | Gates Foundation | 2-Year LTE
Location: Seattle, WA
Employment Type: Full-Time (2-Year Limited-Term Engagement)
Posted: 2 Days Ago
Application ID: B021240
💡 About the Gates Foundation
The Bill & Melinda Gates Foundation is the largest nonprofit organization in the world dedicated to fighting poverty, disease, and inequity. Established on the belief that every person, regardless of identity or circumstance, deserves the chance to live a healthy and productive life, the Foundation drives global transformation through strategic partnerships and groundbreaking innovation.
Employees enjoy an outstanding work culture and an exceptional benefits package that includes comprehensive medical, dental, and vision coverage with no premiums, paid family leave, foundation-funded retirement contributions, and generous PTO. At the Gates Foundation, you’re empowered to thrive — personally and professionally.
🌐 The Global Health Division
The Global Health Division aims to harness cutting-edge science and technology to save lives and improve health outcomes in developing countries. Its work spans the delivery of proven tools, diagnostics, and next-generation medical innovations that are both affordable and accessible.
Within this division, the Integrated Development (IDEV) team operates as a cross-functional hub supporting the Global Development and Gender Equality divisions. IDEV offers expertise in four critical domains:
- Regulatory Affairs
- Chemistry Manufacturing and Controls (CMC)
- Quantitative and Data Science (GHIDE)
- Clinical Design and Informativeness
🧠 About the Role
The Senior Program Officer (SPO), Regulatory Affairs Product Support, will play a key role in accelerating the global access of health innovations. This role focuses on guiding regulatory strategies, ensuring smooth filing processes, and overcoming access barriers — particularly in low- and middle-income countries (LMICs).
As a thought leader, the SPO will provide strategic regulatory support across the Foundation’s product portfolio, which includes:
- Medicines and biologics
- Vaccines and diagnostics
- Medical devices and AI-enabled software
- Gene therapies and live biotherapeutics
You’ll report to the Deputy Director of Regulatory Strategy and Product Support, working collaboratively across multidisciplinary teams to shape global health product development.
⚙️ What You’ll Do
- Lead regulatory strategy for health products from discovery to delivery, ensuring compliance and alignment with global best practices.
- Provide expert guidance on WHO Prequalification and regulatory pathways in LMICs.
- Collaborate with grantees to streamline clinical trial initiation and product registration.
- Leverage facilitated regulatory pathways such as EUMedicines4All, SwissMedic MAGHP, WHO PQ, and WLA CRP.
- Contribute to Target Product Profiles and Integrated Product Development Plans (IPDPs).
- Assess regulatory risks and create mitigation strategies for improved success rates.
- Travel up to 15%, primarily across Europe, Africa, and the U.S.
🎓 Qualifications & Experience
- Advanced degree (PhD, PharmD, MSc, or equivalent) with 10+ years of regulatory or industry experience; OR 20+ years of professional experience in global health regulatory affairs.
- Proven track record in product registration, regulatory strategy, and life-cycle management.
- Strong understanding of FDA, EMA, and WHO PQ processes; familiarity with regulatory authorities in India, China, South Africa, Canada, and the EU.
- Prior experience in infectious disease products and pharmacology preferred.
- Excellent written and verbal communication skills with the ability to convey complex regulatory concepts to diverse audiences.
- Demonstrated success managing complex, cross-functional projects in a fast-paced, mission-driven environment.
💰 Salary & Benefits
- Base Salary Range: $186,400 – $288,800 USD
- Seattle/DC Market Range: $203,100 – $314,900 USD
The Gates Foundation offers competitive pay aligned with its mission-driven values. Salaries are determined by skill level, experience, and expertise.
Employee Benefits Include:
- Fully covered healthcare premiums
- Paid family and parental leave
- Foundation-funded retirement contributions
- Generous vacation and PTO
- Wellness and work-life balance programs
🌈 Inclusion, Diversity & Equal Opportunity
The Gates Foundation is deeply committed to the belief that all lives have equal value. The organization promotes a diverse, equitable, and inclusive workplace that welcomes individuals of all backgrounds.
Applicants and employees receive equal opportunity without regard to race, color, gender, age, religion, national origin, disability, sexual orientation, or veteran status.
If you require an accommodation due to disability during the application process, you may submit a request through the Foundation’s Candidate Accommodations Portal.
🚀 Why Join the Gates Foundation?
At the Gates Foundation, you’ll have the opportunity to:
- Contribute to global change through impactful health innovation.
- Collaborate with the world’s leading experts in science, policy, and development.
- Grow within a diverse and mission-driven organization where your work saves lives.
Put your expertise to use in one of the world’s most influential nonprofits — where your impact goes beyond borders.
📅 How to Apply
Applications are currently open.
Interested candidates can apply via the Gates Foundation Careers Portal using Job ID B021240.
