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Environmental Science Adjunct Applicant Pool - Division of Biological and Physical Sciences

PATH

Environmental Science Adjunct Applicant Pool - Division of Biological and Physical Sciences

Seattle, WA
Part Time
Paid
  • Responsibilities

    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 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 Affairs Officer will report to the Global Head Regulatory, CVIA to 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.

    RESPONSIBILITIES

    • 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.

    Required Skills Required Experience

    • Doctorate (preferred) or Bachelor’s degree plus ten or more years of product development experience, including at least five years of regulatory affairs experience.
    • Demonstrated knowledge of regulatory requirements, procedures and policies related to the conduct of clinical trials research.
    • Excellent communications (both orally and written), interpersonal skills.
    • Ability to work with multi-site, multi-country teams, preferably in low-resource settings.
    • Excellent technical writing skills with high level of attention to detail.
    • Demonstrated experience applying creative solutions to complex issues and problems.
    • Major contributor to all Regulatory submissions.
    • Understanding of international complexities and ability to determine most efficient way to regulatory success.
    • Works with external partners to both implement and lead implementation of work plans.
    • Ability to travel internationally up to 30%.
    • Experience in vaccine research working internationally and with WHO preferred.
    • Demonstrated experience in cross-group collaboration in a matrixed environment.
    • Creative thinker and ability to tackle difficult queries with an open mind and can-do attitude.

    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.

  • Qualifications
    • Master's degree in the discipline of instruction OR Master's in any field AND 15 hours in the discipline OR Sufficient experience in lieu of either requirement, as approved by VPAA
    • Community college teaching and/or online teaching experience desired.
    • Subject matter/content expertise in your field.
    • This person should possess enthusiasm and passion for student learning and be able to respond to the needs of students using a variety of teaching methods including new technologies.