• Regulatory Operations Coordinator

    Job Locations US-IL-Chicago
    ID
    2019-1137
    Category
    Regulatory
    Type
    Full-Time
  • Overview

    The Regulatory Operations Coordinator will support the preparation and management of regulatory submissions including INDs, NDAs, MAAs, etc. in addition to Annual Reports, Health Authority correspondence, meeting packages, and clinical trial supportive documentation. This role will assist with the review and evaluation of technical and scientific reports in support of regulatory submissions regarding company products.

    Responsibilities

    • Assist in content planning and regulatory submission compilation
    • Assist in reviewing and formatting regulatory documents for submission
    • Order and structure data from cross-functional teams to be in-line with health authority requirements
    • Assist in lifecycle management and archiving of regulatory submissions
    • Assist in preparation and review of clinical trial documentation to support Health Authority submissions
    • Maintain regulatory files and correspondence in a format consistent with requirements
    • Keep up with changing regulatory requirements
    • Participate as an active member of project teams as required

    Qualifications

    • Bachelor’s Degree, preferably in a scientific field such as biochemistry or biology, or relevant experience may be substituted
    • Minimum of 1 year of regulatory experience in the pharmaceutical industry
    • Experience with FDA submissions, requirements, and terminology (IND, NDA, PMA, 510K, etc.) highly preferred
    • Experience with eCTD filings preferred
    • Strong skills and experience with Adobe and Microsoft Office Suite, including Word, Excel, and Power Point
    • Competencies:  Verbal and Written Communication skills, Proofreading, Editing, Interpersonal skills, Adaptability, Organizational skills, Prioritization and Project Management skills, Cross-Functional Team focus
    • Position may require periodic evening and weekend work, as necessary to fulfill obligations. Infrequent overnight travel may occur.

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