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.

RESPONSIBILITIES:

• 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.

Required Skills Required Experience

• Bachelor’s degree in a Life Science field plus two or more years of pharma/biotech industry experience or Master’s of Science in Regulatory Affairs.
• Prior responsibility for managing regulatory submissions.
• Demonstrated knowledge of regulatory requirements, procedures and policies related to the conduct of clinical trials research.
• Excellent communications (both orally and written), interpersonal skills.
• Strong project management, business acumen and organizational skills.
• Ability to work with multi-site, multi-country teams, preferably in low-resource settings.
• Advanced proficiency in MS Word, Project, Visio, PowerPoint and Excel.
• Excellent technical writing skills with high level of attention to detail.
• Demonstrated experience applying creative solutions to complex issues and problems.
• Ability to travel domestically and internationally up to 30%.
• Experience with vaccine research and/or trials preferred. Additional experience working in low-resource countries desirable.

Must have legal authorization to work in the United States.

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_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, 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.

• Five years or more negotiating vendor contracts, direct, hands-on experience with parcel, LTL & truckload carriers
• Knowledge in a Logistics Management System
• Five years or more scheduling shipments
• Proven analytical skills with experience working on problems of diverse scope.
• Demonstrated good judgment in selecting methods and techniques for obtaining solutions.
• Excellent business communication skills, both oral and written.
• Proficient knowledge of Microsoft Office (to include Excel, PowerPoint and Outlook)