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, weโre committed to creating an environment for you to thrive both personally and professionally.
The TeamThe 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.
The 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 regulatory systems sits the subdomain or Body of Work - Africa regulatory systems who vision is โAll of Africa has access to quality essential medical products through strong Africa regulatory systems anchored on ML3/WLA agencies, RECs, AMA, reliance and innovation.โ The Africa Regulatory Systems Body of work (BOW), a partnership with the Foundationโs Africa Office, was established at end of 2021. This BOW comprises three workstreams covering the national, regional, and continental levels of the regulatory ecosystem.
Application Deadline: 20/12/24
Your Role
As a Senior Program Officer, Regulatory Affairs, You are a creative, thoughtful, and curious leader who identifies as a problem solver, trusted business partner, and subject matter expert in regulatory affairs. Responsible for managing and developing a portfolio of grants focusing on optimizing regulatory systems through which medical (pharma, vaccines, and diagnostics) and vector control products must go to be and stay marketed legally in Foundation focus countries.
The role and responsibilities of the Senior Program Officer will be focused on working with the multiple National Regulatory Authorities on the continent of Africa, supporting the technical committees as well as offering thought partnership and the needed support to ensure that the opinions/decisions of AMA (African Medicines Agency) are efficiently translated into national decisions. You will promote the application of reliance across agencies and collaborate with our supply chain team to ensure the availability of priority public health commodities in key markets.
This role will be based in Nairobi, Kenya, and will report to the Deputy Director of Africa Regulatory Systems, who is also located in Nairobi, Kenya.
What Youโll Do
1. Manage, develop, and help drive a portfolio of high-impact, complex grants requiring project development and management skills and high-level strategy skills. Responsibilities include:
Manage a complex network of implementing partners/grantees, by conducting site visits, providing technical mentorship, 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 Co-Chairs.
Partner with grantees to develop projects and define key outcomes and achievements. Establish and maintain effective monitoring and evaluation systems and processes to ensure a thorough assessment of performance against milestones and outcomes.
Collaborate with programmatic 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.
2. Represent the foundation to key program-related external constituencies and, as appropriate, on committees related to the area of expertise and responsibilities of the position. This could include formal and informal presentations such as making speeches and attending conferences and other meetings as necessary.
3. Write and produce insightful briefings and other materials on role-relevant key issues for Global Health team members and foundation leadership.
4. This role is responsible for high-quality interactions and clear and consistent communications with grantees and partners in the field.
Your Experience
Advanced degree required with demonstrated years of experience.
MD/PhD, and/or PharmD โ with 11+ years of experience โ preferred
Masterโs/MBA degree in bio-pharmaceutical or medical science, with proven experience.
Minimum of 15 years of experience in Regulatory Affairs and Regulatory Agency involving Vaccines, Biologics, Drugs, and/or Devices (Diagnostics) in Africa โ preferred
Competency 1: Can communicate intricate regulatory and science concepts to partners with a diverse set of backgrounds, including leadership, program staff, grantees, and other foundation operational resources
Competency 2: Experience developing and implementing projects in Africa strongly preferred (other low- and middle-income regions/countries preferred).
Competency 3: Strong problem solving and strategy development experience.
Competency 4: 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 collaborators. Experience in leading projects in Africa is strongly preferred.
Competency 5: Experience in pharmaceutical regulatory affairs, from research and clinical development to post-marketing and lifecycle management (including marketing authorizations) for vaccines, medicines, diagnostics, and/or vector control products, preferred. Significant experience with African medical products regulatory issues strongly preferred.
Competency 6: Demonstrated track record 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.
Competency 7: Experience in conception, design, and management of strategies, initiatives, and programs including experience in managing complex projects and processes, from work plan development to implementation.
Competency 8: 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.
Other Attributes
Proven expertise in project leadership, analysis, interpersonal relations, and both written and verbal communication, with a strong ability to present data and results effectively to diverse international audiences. Experience in leading projects in Africa strongly preferred.
Comfortable in a wide range of cultural, geographic, and operational situations, demonstrating culturally sensitive behavior with a diverse range of people.
Travel will be predominantly in Africa, but travel will also be expected to Seattle, Geneva, and other locations, as needed.
Ability to travel up to 30% domestically and internationally.
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 โ of voices, ideas, and approaches โ 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.