Regulatory Affairs - System Process & Innovation

vetshired.us

Hybrid
Gracs digital strategy projects and systems
Regulatory information management systems
Content management for regulatory submissions
This role supports regional activities for Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems, including content management, submission planning, and regulatory information management

Job Summary

  • This role supports regional activities for Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems, including content management, submission planning, and regulatory information management.
  • The position 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 and processes.
  • Responsibilities include acting as the primary contact for regional users, evaluating regional data for quality issues, and representing regional needs in global project activities and Change Control Boards.

Matching Summary

This role supports regional activities for Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems, including content management, submission planning, and regulatory information management.

Skills & Requirements

Must-have

  • GRACS Digital Strategy projects and systems
  • regulatory information management systems
  • content management for regulatory submissions
  • submission planning & execution
  • regional implementation of GRACS Regulatory systems
  • data quality issues evaluation and action plans

Nice-to-have

  • leading and working in teams
  • change management and business process development
  • technology enablement of business processes
  • automation opportunities
  • cross-functional team leadership

Key Requirements

  • 2-4 years experience in Regulatory Affairs or Operations
  • 3+ years experience implementing/supporting regulatory information systems
  • Demonstrated experience using the Veeva platform
  • Experience in project management methodologies
  • Experience with change management

Work Rights

Not specified

Tailored Resume

Cover Letter