PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide.
PATH’s Center for Vaccine Innovation and Access brings together our expertise across every stage of the long and complex process of vaccine research, development, and delivery to make lifesaving vaccines widely available to children and communities across the world. CVIA’s current portfolio encompasses more than two dozen vaccines either in development or already in use to protect against 15 different diseases. Our focus is on vaccines to address the leading diseases that claim children’s lives worldwide: pneumonia, diarrheal disease, and malaria; as well as other global health priorities, such as polio and meningitis. We work in partnership with national health ministries, pharmaceutical manufacturers, donors, international financing and regulatory organizations, and many others. PATH has led numerous global partnerships, including the award-winning Meningitis Vaccine Project and the Malaria Vaccine Initiative, which helped develop the first malaria vaccine candidate recommended for pilot implementation.
Based in PATH’s Seattle, WA office, the Regulatory Affairs Officer will report to the Senior Regulatory Strategist to provide regulatory support and guidance to various vaccine development projects at PATH. The incumbent will develop regulatory strategies, prepare documents for regulatory authorities and WHO, review protocols and other documents for compliance with appropriate guidelines and regulations, and perform other duties as assigned.
- Develop regulatory strategy plans for vaccine development programs
- Oversee, prepare and ensure timely submission of high-quality regulatory documents for US and international regulatory authorities (i.e., INDs, CTAs, Annual Reports, BLAs, Meeting Requests, Briefing Documents, etc.).
- Track the status of regulatory submissions for vaccine programs.
- Maintain surveillance on long-range and emerging issues related to the regulation of vaccine development in the US and internationally.
- Provide interpretive analysis of complex regulatory guidance documents, regulations and directives that affect CVIA projects and advise other PATH staff regarding their applicability and impact.
- Provide input and support in the development of policies and procedures related to regulatory affairs.