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Senior Regulatory Affairs Officer, Center for Vaccine Innovation and Access
Tracking Code11855Job Description
PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships, and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing health challenges.
PATH’s Center for Vaccine Innovation and Access (CVIA) spans every stage of the complex process of vaccine research, development, and introduction to make lifesaving vaccines widely available to women, 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 18 different diseases, including diarrheal disease, malaria, meningitis, pneumonia, polio, and COVID. 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 world’s first malaria vaccine recently recommended by the WHO. PATH’s work on vaccine development and introduction encompasses activities including discovery, preclinical development, clinical research and development, process development and manufacturing, regulatory and vaccine introduction. Over 25 candidates and vaccines are currently in our portfolio in the following disease areas – Malaria, Enteric and Diarrheal Diseases, Polio, Respiratory Tract Infections and Meningitis, HPV and Vector-borne viral diseases (e.g., Japanese Encephalitis, Yellow Fever) – and in the cross-cutting areas of Maternal Immunization and Immunization Systems Strengthening.
CVIA is hiring a Regulatory Affairs Officer who will report to the Global Head Regulatory, CVIA and will provide regulatory leadership, 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
- Work closely with vaccine development teams to design integrated development plans that ensure regulatory compliance and optimize program efficiency
- 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
- Advanced degree (Doctorate preferred) or bachelor’s degree (required) plus at least five years of regulatory affairs experience or ten years of product development experience as a major contributor to regulatory submissions
- Demonstrated knowledge of regulatory requirements, procedures and policies related to the conduct of clinical trials research
- Demonstrated experience applying creative solutions to complex issues and problems with an open mind and can-do attitude
- Excellent oral and written communication skills and interpersonal skills
- Prior experience working on multi-site and multi-country teams (preferably including in low-resource settings) to lead implementation of regulatory submissions
- High level of attention to detail and significant experience in project management
- Understanding of international complexities and ability to determine most efficient way to regulatory success
- Experience in vaccine research working internationally and with the World Health Organization (WHO) preferred
- Demonstrated experience in cross-group collaboration in a matrixed environment
- Ability and willingness to travel internationally up to 30%
- Must have legal authorization to work in the United States.
PATH is a diverse nonprofit organization that creates a culture of collaboration and partnership. 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 $116,424-$200,604, 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, disability and retirement benefits. For more details click here.
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, D.C.
COVID-19 Vaccine Requirement
PATH has instituted a COVID-19 vaccine mandate for all employees, interns, consultants, and temporary staff based in the United States. Individuals selected for job opportunities in the United States must be fully vaccinated, and show proof of vaccination status, upon hire. Individuals are considered fully vaccinated 2 weeks after their second dose in a 2-dose series, such as Pfizer or Moderna, or 2 weeks after a single-dose vaccine, such as Johnson & Johnson. Individuals with medical issues or sincerely held religious beliefs that prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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, gender identity or orientation, 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.
Learn more here
Job posted: 2023-01-03