Job Description
Daily archiving of regulatory submission documents and health authority correspondence received from CROs, external partners, and Regulatory Affairs leads. Create and/or update eDMS with relevant information to support future search and retrieval of archived submissions and correspondence. Assist with transfer of drug applications / submissions, Health Authority correspondence, and other associated regulatory documents from the regulatory archive, shared drive folders, and off-site storage that are associated with products being transferred or sold to other pharmaceutical companies. Support inspection readiness and preparation activities. Contact and work with internal subject matter experts and/or external partners to determine the completeness of drug application chronologies and/or resolve issues, as needed

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