The Regulatory Affairs Operations role supports 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
The Regulatory Affairs Operations role supports regional activities for Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems, including content management, submission planning, and health registration.
This role partners with Innovation & Information Management (IIM), Business System Owners (BSOs), and regional stakeholders to ensure successful regional implementation and continuous enhancement of GRACS Regulatory systems.
Primary activities include working with various GRACS functions, understanding regional needs, participating in change control boards, providing user support, and assisting in training development.
Matching Summary
The Regulatory Affairs Operations role supports 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
GRACS Digital Strategy projects
regulatory information management systems
Veeva platform experience
cross-functional team leadership
change management experience
Nice-to-have
adapt procedures to regional needs
automation opportunities
dissemination of knowledge
align activities and share best practices
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 implementing/supporting regulatory information systems