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.

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📌 Regulatory Data & Systems Operations Lead (Barcelona)
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📍 Barcelona