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 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 17 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 Regulatory Project Coordinator reports directly to the Global Head of Regulatory and provides overall project management and coordination for the CVIA Regulatory Team, which currently is managing 25 projects. This role works with the Global Head and the Regulatory Officers to manage all regulatory submissions, including creating and maintaining Smartsheet timelines. In addition, this person provides overall project coordination for the regulatory team by creating and maintaining dashboard reports, templates, meeting management, and Veeva document management. Specific job duties are described below.

RESPONSIBILITIES

• Regulatory submission project management – For each regulatory submission:

  • Develop, maintain, track and manage Smartsheet project plans for regulatory submissions
  • Work with the Regulatory Officer to create specific templates for individual submission documents
  • Create review requests for internal and external reviewers of the regulatory submissions
  • Track review timelines
  • Assist Regulatory Officer in consolidation and resolution of review comments
  • Assist Regulatory Officer with QC of regulatory submissions
  • Manage publication to NRA with external partner

• Regulatory team project coordination

  • Manage a library of international regulatory guidelines and regulations according to National Regulatory Authorities (NRAs)
  • Update and publish dashboard reports for ongoing regulatory projects and work with Regulatory Officers to ensure accuracy of reports
  • Develop and manage a system to ensure that PATH regulatory responsibilities are met in a timely manner; this would include a report of upcoming regulatory submissions for regulatory team planning and communication to other departments
  • Develop and maintain database of all regulatory submissions

• Document Management

  • Serve as business administrator for regulatory team in Veeva
  • Create metadata and upload regulatory submissions into Quality Docs Vault
  • Troubleshoot as necessary for regulatory team

• Meeting Management

  • Facilitate weekly regulatory team meetings including agenda development, meeting minutes, and tracking action items
  • Manage annual retreat including agenda development and facilitation
  • Work with the team to identify and schedule guest speakers throughout the year

• Work with the Global Head and Regulatory Officers to prepare proposals for functional area

Required Skills Required Experience

• Bachelor's degree and four years of relevant experience.
• Articulate communicator, excellent oral and written communication skills in English.
• Proficiency in the application of Microsoft Office Suite with an emphasis on proficiency in Outlook, Word, PowerPoint and Excel. Advanced experience with Smartsheet preferred.
• Proven ability to work independently and make recommendations for process improvement.
• Extremely detail oriented.
• Prefer prior experience in uploading regulatory documents into Veeva Quality Docs Vault with creation of meta data.
• Strong interpersonal and organizational skills with a proactive nature.
• Demonstrated ability to work effectively in a multi-site organization and a team-based structure. At least one year of work experience with a global health nonprofit or organization with international partners preferred.
• Must have legal authorization to work in the United States.

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 $74,672-109,200. 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.

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.

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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.