The Regulatory Operations Specialist ensures accurate and consistent regulatory data management, supporting analysis, standardization, and reporting to maintain compliance. The role also supports the transition to a unified regulatory data platform, ensuring harmonized data practices, data integrity, and effective coordination across Regulatory Affairs.- Implement the RIM & DMS project on schedule, coordinating with the external provider, and manage electronic document systems to ensure compliant and accessible regulatory records.- Support Regulatory Affairs and IT teams in projects involving data analysis, data migration, and system integrations, identifying discrepancies and aligning data across platforms.- Maintain regulatory databases and platforms compliant with requirements (PLM, IDMP,



XEVMPD), manage Pharmacopoeia updates (BP, EP, USP), and provide regulatory intelligence for decision-making.- Review and harmonize local Regulatory Affairs folders across affiliates, update SOPs, and propose process/system improvements to enhance data quality, efficiency, and compliance (including KPIs).- Collaborate with cross-functional and integral Regulatory Affairs teams to ensure timely deliverables and operational alignment, and stay updated on changes in agencies’ portals and relevant HA/EMA/CHMP updates and webinars.#J-18808-Ljbffr

📌 Systems Operations Specialist – Regulatory Affairs (Barcelona)
🏢 Actual Talent
📍 Barcelona