Senior Program Officer, Regulatory

2 weeks ago

Johannesburg, Gauteng, South Africa Bill & Melinda Gates Foundation Full time

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 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 "All of Africa has access to quality essential medical products through strong Africa regulatory systems anchored on ML3/WLA agencies, RECs, AMA, reliance and innovation." The Africa Regulatory Systems Body of work (BOW), a partnership with the Africa Regional 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: June 6th, 2024.

Your Role

As the Senior Program Officer Regulatory, you will report to the Deputy Director, Africa Regulatory Systems and should be able to work from our Johannesburg Africa Regional Office. You are creative, thoughtful, and curious leader that 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. You will manage and coordinate the strengthening of national regulatory agencies to attain WHO maturity level 3 and ultimately WHO listed authorities as well as the promotion of cooperation and reliance across agencies. You will also support efforts to strengthen regulatory capacities to combat substandard and falsified medical products.

What You'll Do

Manage, develop, and help drive a portfolio of high-impact, complex grants requiring project development and management skills, as well as high-level strategy skills. Responsibilities include: 1) Manage a complex network of implementing partners / grantees, for example by conducting site visits, providing technical guidance, convening meetings of key partners, and applying and evaluating performance objectives. 2) 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. 3) Partner with grantees to develop projects and define key outcomes. Ensure appropriate monitoring and evaluation systems and processes are established to produce robust evaluation of performance against achievements and outcomes. 4) Collaborate with program and functional team members to manage internal processes, portfolio progress, documentation, and grant budget information and reporting. 5) Serve as a point of contact on portfolio-related issues for key internal and external partners. Represent the foundation to key program-related external constituencies and, as appropriate, on committees related to area of expertise and responsibilities of the position. This could include both formal and informal presentations such as making speeches, attending conferences and other meetings as necessary. Write and produce informative briefings and other materials on role relevant key issues for Global Health team members and foundation leadership. This role is responsible for high quality interactions and clear and consistent communications with grantees and partners in the field. Travel will be predominantly in Africa, but travel will also be expected to Seattle, Geneva, and other locations, as needed.

Your Experience

Advanced degree required with demonstrated experience of atleast 7 years or more/7+ years. MD/PhD, and/or PharmaD is preferred; or Master's/MBA degree in bio-pharmaceutical or medical science; or experience in Regulatory Affairs and Regulatory Agency involving Vaccines, Biologics, Drugs, and/or Devices (Diagnostics) in Africa is preferred. Can communicate intricate regulatory and scientific concepts to partners with a diverse set of backgrounds, including leadership, program staff, grantees, and other foundation operational resources. Experience developing and implementing projects in Africa strongly preferred (other low- and middle-income regions / countries preferred). Strong problem solving and strategy development experience. 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 partners. Experience in leading projects in Africa strongly preferred. Experience in pharmaceutical regulatory affairs, from research and clinical development to post-marketing and life-cycle management (including marketing authorizations) for vaccines, medicines, diagnostics, and/or vector control products, preferred. Significant experience with African medical products regulatory issues strongly preferred. 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. 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. Project management skills, organization skills, and relationship management skills necessary to work daily with the regulatory experts in any of our partner systems to help them implement.

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 .

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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