Regulatory Operations Associate - Bethesda - TRI

    TRI
    TRI Bethesda

    1 hour ago

    $50,000 - $85,000 (USD) per year *
    Description

    Job Title
    Regulatory Operations Associate
    Location
    Bethesda, MD 20817 US (Primary)
    Category
    Regulatory Affairs
    Job Type
    Full-Time
    Salary Range
    54, ,000.00/YEAR
    Education
    Bachelor's Degree
    Travel
    None
    Job Description

    • Prepare standard documentation supporting regulatory filings and distribution to stakeholders.
    • Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents.
    • Maintain effective high-profile communications and interactions with colleagues, collaborators, and clients as appropriate.
    • Draft, edit, and distribute various documents as needed based on templates and work instructions.
    • Develop and maintain work process tools to promote efficiency and productivity. These may include templates, SOPs, work instructions, checklists, etc.
    • Track regulatory activity, maintain, and update databases, and ensure that records are complete and current.
    • Provide other administrative regulatory support as needed.
    Job Requirements
    • Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well.
    • Superior organizational skills and customer service abilities are required.
    • Experience publishing regulatory submissions using electronic submission software and proficiency in preparing documents that are compliant with electronic submission standards is preferred.
    • Proficiency in MS Office (Word, Excel, and Outlook); experience with SharePoint is a plus.
    • Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.
    • Familiarity with Good Clinical Practices and/or experience of working in an FDA-regulated environment is desirable.
    • General knowledge of the drug and vaccine development process or clinical trials is a plus.
    • This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.
    * This salary range is an estimation made by beBee
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