The Regulatory Affairs Operations role will support regional activities associated with the implementation and support of Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems
Job Summary
The Regulatory Affairs Operations role will support regional activities associated with the implementation and support of Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems.
This role partners with Innovation & Information Management (IIM), Business System Owners (BSOs) and key regional stakeholders to ensure the successful regional implementation of GRACS Regulatory systems and to support continuous enhancements of capabilities and processes.
Primary Activities include working with colleagues from various GRACS functions to deliver on regional objectives, understanding regional needs, and participating in the development of communications and change management initiatives.
Matching Summary
The Regulatory Affairs Operations role will support regional activities associated with the implementation and support of Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems.
Skills & Requirements
Must-have
Veeva platform experience essential
Regulatory Affairs or Regulatory Operations
Implement/support regulatory information systems
Business Process Modeling
Change Management
Project Management methodologies
Nice-to-have
Lead and influence others
Cross-functional team leadership
Develop training materials
Communication strategy development
Automation-based solutions
Key Requirements
Min of 2-4 years’ experience
At least 3 years’ experience implementing/supporting regulatory information systems
Bachelor’s degree in science, information technology or Pharmacy