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    Regulatory Affairs Specialist Project Lead I - Washington, United States - Integrated Resources

    Integrated Resources
    Integrated Resources Washington, United States

    1 week ago

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    Description

    Job Title:
    Regulatory Affairs Specialist Project Lead I

    Location:
    Washington D.C., DC (Fully Remote)

    Duration: 06 months

    Part-Time Role- (Mon - Fri 9 AM - 1 PM EST)

    Job Description:

    Fully Remote Part-Time Role with slight flexibility for different time zones. Candidates must be located in the US. Possibility of extension.

    • 3-6 years of experience in pharma regulatory-related roles across all therapeutic areas
    • Fluent in online searches and research
    • Proficient in MS Office applications
    • Ability to create presentations

    Nice to Have Skills:

    Writing, analyzing data, research write-ups.

    Product Responsibilities:

    Accountable for supporting regulatory policy efforts within the Regulatory Science and Policy team. Responsibilities include working with cross-functional teams on strategic and tactical product issues, FDA engagement, and ensuring effective execution for new products.

    Duties:

    • Work with regulatory leads on product strategy and FDA engagement
    • Monitor emerging regulatory policy issues
    • Coordinate internal teams to develop responses on regulatory issues
    • Lead advocacy efforts for regulatory policy areas

    Education, Experience and Skill Requirement:

    • Minimum B.S.; M.S., Pharm D, MD, PhD or equivalent preferred
    • Minimum 3 years in Regulatory Affairs
    • Familiarity with drug/biologic development process
    • Excellent communication and organizational skills
    • Ability to lead multiple initiatives effectively
    • Self-motivated and results-oriented

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