Senior Program Officer, Regulatory Affairs

Job Posting Organization:
The organization is the largest nonprofit dedicated to fighting poverty, disease, and inequity globally. Founded on the principle that all individuals, regardless of their identity or circumstances, should have the opportunity to lead healthy and productive lives, the foundation emphasizes the importance of diversity among its employees to reflect the global populations it serves. The organization offers an exceptional benefits package that includes comprehensive medical, dental, and vision coverage with no premiums, generous paid time off, paid family leave, retirement contributions, regional holidays, and opportunities for employees to engage in various community initiatives. The foundation is committed to fostering a workplace environment that supports both personal and professional growth for its employees.

Job Overview:
As a Senior Program Officer in Regulatory Affairs, you will report to the director" style="border-bottom: 1px dotted #007bff !important;">Deputy Director of Regulatory, Integrated Development. This role is designed for a creative and thoughtful leader who is a problem solver and a trusted business partner with expertise in regulatory affairs, particularly in European regulatory systems and international regulatory frameworks. Your primary responsibility will be to manage and develop a portfolio of grants aimed at optimizing regulatory systems for medical products, including medicines, vaccines, and diagnostics, ensuring they are safely marketed and legally procured in low-income countries, primarily in sub-Saharan Africa. The position involves working closely with the Africa regulatory systems Deputy Director to establish an effective African Medicines Agency (AMA) and collaborating with the Global regulatory systems Deputy Director to support partnerships with the World Health Organization (WHO) and other regulatory authorities. This role is pivotal in facilitating the development and execution of strategies that enhance regulatory systems globally, particularly in Africa.

Duties and Responsibilities:
Your responsibilities will include managing a complex network of implementing partners and grantees, conducting site visits, providing technical guidance, and convening stakeholder meetings. You will review letters of inquiry and grant proposals, making funding recommendations and drafting proposal summaries for senior leadership. Collaborating with grantees, you will define key outcomes and milestones, ensuring robust monitoring and evaluation systems are in place. You will also manage internal processes related to portfolio progress, documentation, and grant budget reporting. As a point of contact for portfolio-related issues, you will represent the foundation to external constituencies and produce informative briefings on key issues for the Global Health team and foundation leadership. Travel is expected to be around 35%, primarily in Europe, Africa, and the United States.

Required Qualifications:
Candidates must possess an advanced degree (MD, PhD, or LLM/JD or equivalent) with significant expertise in regulatory affairs or experience in a national/regional medical products regulatory agency. Deep expertise in regulatory affairs, particularly involving vaccines, biologics, drugs, and diagnostics, is essential. Experience within the European Medicines Agency (EMA) and the European regulatory system is preferred, as is experience with the WHO or related institutions. Strong project leadership, analytical, interpersonal, and communication skills are necessary, along with the ability to communicate complex regulatory concepts to diverse audiences.

Educational Background:
An advanced degree is required, with a preference for candidates holding an MD, PhD, or LLM/JD (or equivalent). Candidates should have significant expertise in regulatory affairs, particularly in relation to medical products and regulatory agencies.

Experience:
Candidates should have demonstrated experience in regulatory affairs, particularly within the context of vaccines, biologics, drugs, and diagnostics. Experience in developing and implementing regulatory projects in Europe and Africa is strongly preferred, along with a proven track record of project management and leadership in complex environments.

Languages:
Conversational competency in French, in addition to English, is preferred. The ability to communicate intricate regulatory and scientific concepts to a diverse audience is essential.

Additional Notes:
This position is a limited-term role for 2 years. The salary range for this role is between $186,400 and $288,800, with higher ranges for positions based in Seattle and Washington D.C. New hires typically fall between the minimum and midpoint of the salary range, depending on their skills and experience. The organization is committed to diversity, equity, and inclusion in its hiring practices, ensuring equal opportunity for all applicants.