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 Af...