PATH’s Center for Vaccine Innovation and Access (CVIA) 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 fifteen 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.

The Director of Regulatory Strategy will report to the Global Head of Regulatory and will work with the Regulatory Manager to develop regulatory strategies for vaccine projects. The incumbent will be a creative problem solver and will work with the Global Head of Regulatory to help define future expansion of the regulatory department as a center of excellence for global regulatory expertise that will provide strategic solutions to improve the international regulatory environment.

Responsibilities:

• Develop regulatory strategies for vaccine development and technical assistance projects
• Work with Regulatory Managers to define regulatory strategic input to integrated product development plans
• Participate in regulatory sub teams and assist Regulatory Managers as needed
• Provide mentorship to junior colleagues
• Work with Global Head of Regulatory to identify opportunities for strategic global regulatory enhancement programs
• Serve as a resource for Associate Director of Regulatory Management and Regulatory Managers
• 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
• May serve as designee for Global Head of Regulatory on PATH sponsored projects as needed

Required skills and experience:

• Advanced degree (MD or PhD) in life sciences plus at least ten years of vaccine regulatory affairs experience or a combination of 15 years of regulatory and product development experience as a major contributor to regulatory submissions
• Experience developing global regulatory strategies for vaccines for infectious diseases
• Experience working with WHO for the prequalification of vaccines
• Experience in regulatory submissions in low resource settings
• Understanding of international complexities and ability to determine the most efficient way to regulatory success
• Prior experience working on multi-site and multi-country teams (including in low- resource settings) to lead implementation of regulatory submissions
• Experience managing people and working in a matrix environment with cross-functional teams
• Demonstrated experience applying creative solutions to complex issues and problems with an open mind and can-do attitude
• Strong organizational and project management skills
• High attention to detail
• Excellent oral and written communication and interpersonal skills
• Excellent technical writing skills
• Ability and willingness to travel internationally up to 30%
• Must have legal authorization to work in the US, Belgium, or Switzerland. Fully remote candidates will be considered.

PATH is a diverse nonprofit organization that creates a culture of collaboration and partnership. Learn more about the impact you can make globally here.

We offer our employees a competitive salary and generous benefits. For candidates based in the U.S., the annual salary range for this position is $200,000-$250,000. The final salary is based on a variety of objective factors. PATH provides a comprehensive benefit package that includes 15 vacation, 10 holiday, 2 personal and 12 sick days per year; medical and dental plans; life insurance; disability and retirement benefits. For more details click here.

Hybrid Work

PATH operates within a hybrid workplace model unless otherwise noted. Hybrid employees must reside within commuting distance to one of our PATH offices. PATH’s US offices are located in Seattle, WA and Washington, DC. Fully remote candidates will be considered.

PATH is dedicated to building an inclusive workforce where diversity is valued.

PATH is an equal opportunity employer. Every qualified applicant will be considered for employment.

PATH does not discriminate based on race, color, religion, caste, gender, sexual orientation, gender identity, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.