Regulatory Operations Specialist - Germantown - Precigen

    Precigen
    Precigen Germantown

    19 hours ago

    Description

    As an integral member of Precigen's Regulatory Affairs team, this highly motivated Regulatory Operations Specialist/Senior Specialist will work collaboratively with cross-functional teams to support the generation of content for regulatory submissions.

    • Publish and submit regulatory submissions to competent authorities.
    • Manage document preparation, including formatting, approval, archiving, and tracking through Veeva Vault RIM suite.

    This role entails responsibilities such as document quality control checks for others in the department and participation in process improvement initiatives.


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