Regulatory Operations Specialist - Germantown - Precigen

    Precigen
    Precigen Germantown

    23 hours ago

    $73,000 - $118,000 (USD) per year
    Description

    Precigen is seeking a Regulatory Operations Specialist to join our team in Germantown, Maryland. This specialist will be an integral member of the Regulatory Affairs team responsible for production, compilation and distribution of publish-ready documents for submission to regulatory authorities.

    The key responsibilities include:

    • Ensuring completeness and quality of regulatory submissions from the operations perspective.
    • Publishing and submitting regulatory submissions to competent authorities.
    • Maintenance archiving and tracking of regulatory submission documentation ensuring compliance with company document standards
    In addition this position entails format edit review generate publish ready PDFs using standardized templates.<hr><p>This role requires strong knowledge-base eCTD requirements ICH guidelines Competent Authorities guidance documents as they apply electronic submissions proficiency MS Office Suite familiarity MS Project experience publishing eCTD submissions highly desirable</p><p>DESIRED KEY COMPETENCIES:
    (•) Intermediate advanced skills Microsoft Word Adobe Acrobat Pro DC StartingPoint Templates eCTD publishing EDMS such as Veeva Vault
    (•) Strong organization time management skills ability work multiple projects simultaneously excellent attention detail
    (•) Ability understand execute companys mission values Clear communication both oral written form demonstrated ability coordinate stakeholders exhibition highest degree ethical trustworthiness,"}

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