Regulatory Affairs Operations

Newyorkbioconnect

Hybrid
Regulatory affairs digital strategy
Gracs digital strategy projects
Veeva platform experience
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 regulatory information management

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 regulatory information management.
  • This role partners with Innovation & Information Management (IIM), Business System Owners (BSOs), and key 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 direct support to system users, and assisting in developing global regulatory training.

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 regulatory information management.

Skills & Requirements

Must-have

  • Regulatory Affairs Digital Strategy
  • GRACS Digital Strategy projects
  • Veeva platform experience
  • Business Process Owners (BPOs)
  • Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy

Nice-to-have

  • Cross-functional team leadership
  • Continuous enhancement of capabilities
  • Automation opportunities
  • Regional needs and changes
  • Change management and business process development

Key Requirements

  • Min of 2-4 years’ experience in Regulatory Affairs, or Regulatory Operations, and/or pharmaceutical manufacturing
  • At least 3 years’ experience in implementing and/or supporting regulatory information systems
  • Bachelor’s degree in a science, information technology or Pharmacy discipline required
  • Advanced degree preferred (engineering or scientific discipline, MBA)

Work Rights

Not specified

Tailored Resume

Cover Letter