The Regulatory Affairs Operations role supports regional activities for Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems
Job Summary
The Regulatory Affairs Operations role supports regional activities for 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 successful regional implementation and support continuous enhancements.
Primary activities include working with various GRACS functions, understanding regional needs, participating in change control boards, and providing direct support to system users.
Matching Summary
The Regulatory Affairs Operations role supports regional activities for Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems.
Skills & Requirements
Must-have
Regulatory Affairs Digital Strategy
GRACS Digital Strategy projects
Veeva platform experience
Business Process Owners (BPOs)
cross-functional team leadership
Nice-to-have
continuous enhancements of capabilities
automation opportunities
dissemination of knowledge
collaboration with Regional SPRI staff
Key Requirements
Min of 2-4 years’ experience in Regulatory Affairs, Regulatory Operations, or pharmaceutical manufacturing
at least 3 years’ experience in implementing/supporting regulatory information systems
Bachelor’s degree in science, information technology or Pharmacy discipline
Demonstrated experience using the Veeva platform is essential