Sr.StaffRIMSPlatformOwner

## Accountabilities You will serve as the enterprise owner of the RIMS platform, defining its roadmap, ensuring compliance, and enabling scalable digital regulatory operations across the organization. You will also act as the key bridge between business stakeholders, IT, and vendors to ensure seamless execution and continuous improvement. Own the end-to-end RIMS platform lifecycle, including requirements, configuration, validation, deployment, and ongoing optimization Define and execute the global RIMS roadmap aligned with regulatory strategy and digital transformation goals Ensure system compliance with GxP, 21 CFR Part 11, and CSV requirements, maintaining validated state across all changes Harmonize regulatory workflows across multiple operating units to ensure consistency and global alignment Lead integration of AI, automation, and intelligent agents to improve efficiency and decision-making in regulatory processes Partner with Regulatory Affairs, Quality, and IT teams to translate business needs into scalable system capabilities Oversee vendor relationships and ensure delivery of platform enhancements and system stability Drive continuous improvement initiatives across regulatory systems, data flows, and reporting capabilities Requirements This role requires deep experience in regulated environments, strong ownership of enterprise systems, and the ability to translate complex regulatory needs into scalable technology solutions. Bachelor’s degree with 14+ years of experience, or Master’s/PhD with 12+ years in regulated industry environments Proven experience as a systems owner, business analyst, or platform lead within Regulatory Affairs or Quality functions Strong knowledge of RIMS and/or eQMS platforms (e.g., MasterControl, Veeva, SmartSolve, Regdesk, or similar) Solid understanding of GxP regulations, 21 CFR Part 11, and computer systems validation (CSV) principles Experience leading large-scale digital transformation or enterprise platform implementations Ab