Support regional activities for Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems, including content management, submission planning, and health registration
Job Summary
Support regional activities for Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems, including content management, submission planning, and health registration.
Partner with Innovation & Information Management (IIM), Business System Owners (BSOs), and regional stakeholders to ensure successful regional implementation and continuous enhancement of GRACS Regulatory systems.
Provide primary contact for regional users regarding system usage, existing processes, and process improvement initiatives, including evaluation of regional data and implementation of action plans for data quality.
Matching Summary
Support regional activities for Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems, including content management, submission planning, and health registration.
Skills & Requirements
Must-have
Regulatory Information Systems support
GRACS Digital Strategy implementation
Business process adaptation
User training and support
Data quality evaluation
Cross-functional team leadership
Nice-to-have
Regional needs assessment
Continuous process enhancement
Automation-based solutions exploration
Global project collaboration
Change management expertise
Key Requirements
2-4 years' experience in Regulatory Affairs or Operations
3+ years' experience implementing/supporting regulatory information systems