• Manage the coordination and publishing of submissions to regulatory Health Authorities in the appropriate eCTD format using Veeva RIM • Monitor submission timelines and proactively identify risks or delays, leveraging Veeva RIM dashboards and reporting tools for visibility and tracking • Provide training and guidance to regulatory staff on Veeva RIM functionality and best practices • Implement and optimize Veeva RIM workflows to streamline submission processes and improve operational efficiency • Maintain accurate, audit-ready records and metadata within Veeva RIM to support regulatory compliance and inspection readiness • Provide support to Regulatory Staff by processing submission objects and content plans within Veeva RIM, ensuring proper document formatting, and incorporating bookmarks and hyperlinks as required • Archive regulatory submissions and correspondences; process submission metrics and reports as necessary • Collaborate with QA, IT, and/or 3rd parties to ensure Veeva RIM, Omnicia, docuBridge, etc. system configurations meet evolving regulatory and business needs • Maintain regulatory chronologies and trackers as needed • Maintain current knowledge of existing and emerging regulations, standards, or guidance’s related to electronic submission and publishing requirements • Provide support in the development of standard operational procedures, work instructions, and systems to ensure regulatory compliance • Coordinate with external partners for operational deliverables including support of publishing and/or Veeva RIM on and off boarding • Manage and resolve publishing-related issues encountered during validation as needed • Maintain regulatory submission tracking reports for CRB and MRB • Maintain clinical trial regulatory compliance tracking for ongoing development programs • Establish and maintain the regulatory archive in the eTMF Veeva Vault structure as necessary • Support the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and teamwork • Other duties as assigned