Systems Operations Specialist – Regulatory Affairs

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 global 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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