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The Regulatory Affairs Operations position at 539 involves supporting regional activities associated with Global Regulatory Affairs, Compliance, and Safety Digital Strategy projects. The role requires collaboration with various stakeholders to enhance regulatory systems and processes, focusing on data quality and user training.
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Job Summary
Support regional activities for Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems.
Partner with Innovation & Information Management (IIM), Business System Owners (BSOs), and regional stakeholders for system implementation and enhancements.
Provide primary contact for regional users regarding system usage, processes, and improvement initiatives, including data quality evaluation and action plans.
Matching Summary
Match Score: 75
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The Regulatory Affairs Operations position at 539 involves supporting regional activities associated with Global Regulatory Affairs, Compliance, and Safety Digital Strategy projects. The role requires collaboration with various stakeholders to enhance regulatory systems and processes, focusing on data quality and user training.
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Skills & Requirements
Must-have
Regulatory Affairs Digital Strategy
GRACS Digital Strategy projects
Veeva platform experience
Business Process Owners (BPOs)
Regional needs and changes
Global project activities
Nice-to-have
Cross-functional team leadership
Continuous enhancements of capabilities
Automation opportunities
Change management expertise
User training and support
Key Requirements
Min of 2-4 years’ experience in Regulatory Affairs or Regulatory Operations
At least 3 years’ experience implementing/supporting regulatory information systems