Global Regulatory Affairs Operations - Content Management Specialist

We are seeking a highly motivated and detail-oriented Global Regulatory Affairs Operations Specialist to join our Content Management team. In this role, the successful candidate will support the Content Management Manager and ensure the effective implementation and management of the Veeva RIM solution.

The role involves supporting existing submission tracking and planning tools, collaborating with cross-functional teams including Regulatory Affairs, CMC, IT, PV, and Quality to manage regulatory processes within the Veeva platform.

Main Activities & Responsibilities:

• Support the implementation of Veeva RIM (Submission and Submission Archive Modules), including design, configuration, validation, testing, migration, training, and deployment.
• Work with stakeholders to map current processes and identify opportunities to optimize workflows within Veeva RIM, ensuring consistency and harmonization.
• Support and enhance the current regulatory project planning, tracking, and reporting tools, including developing dashboards and reports, and integrating with Veeva modules.
• Develop and maintain SOPs and work instructions for Veeva Submission and Submission Archive.
• Post-implementation, maintain the system, support end-users, troubleshoot issues, and gather feedback for improvements.
• Coordinate with IT and vendors on technical issues and system enhancements.
• Maintain the current Document Management System until Veeva is fully operational.
• Assist the Content Management Manager with developing scorecards, monitoring team activities via dashboards, and providing insights for continuous improvement.

Job Requirements:

• Master's degree in a relevant scientific or IT discipline.
• Experience in Global Regulatory Affairs and/or Operations, preferably in the pharmaceutical industry.
• Experience with Veeva RIM implementation and management is preferred.
• Strong knowledge of global regulatory requirements (e.g., FDA, EMA).
• Excellent planning, organizational, analytical, problem-solving, and communication skills.
• Effective team player capable of working across organizational levels.
• Fluent in English, both written and oral.