Regulatory Affairs Operations

39med

Hybrid
Regulatory affairs digital strategy
Gracs digital strategy projects
Veeva platform experience essential
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 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
  • Veeva platform experience essential
  • Business Process Modeling
  • Process Improvements

Nice-to-have

  • Cross-functional team leadership
  • Continuous enhancements of capabilities
  • Automation opportunities
  • Change management expertise
  • Develop training materials

Key Requirements

  • Min of 2-4 years’ experience in Regulatory Affairs
  • At least 3 years’ experience in implementing/supporting regulatory information systems
  • Bachelor’s degree in science, IT, or Pharmacy
  • Experience in project management methodologies
  • Experience with change management

Work Rights

Not specified

Tailored Resume

Cover Letter