Location
Bernards
Job Type
Full-time
Posted
June 02, 2026
Job Description
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
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We ar...
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
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We ar...