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
Regulatory Affairs Digital Strategy
GRACS Digital Strategy projects
Regulatory information management systems
Veeva platform experience
Cross-functional team leadership
Nice-to-have
Continuous process enhancements
Automation-based solutions
Change management expertise
Business process development
Key Requirements
Bachelor’s degree in science, IT, or Pharmacy
Min 2-4 years' experience in Regulatory Affairs/Operations or pharma manufacturing
At least 3 years' experience implementing/supporting regulatory information systems