Regulatory Affairs Operations

Merck & Co., Inc., Rahway, NJ, USA

Hybrid
Regulatory affairs digital strategy
Gracs digital strategy projects
Regulatory information management systems
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 various departments to ensure successful regional implementation of GRACS Regulatory systems and supports continuous enhancements.
  • Primary activities include collaborating with cross-functional teams, providing user support, developing training, and representing regional needs in global project activities.

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
  • Regulatory Information Management Systems
  • Business Process Owners (BPOs)
  • cross-functional team leadership
  • Veeva platform experience

Nice-to-have

  • continuous enhancements of capabilities
  • automation opportunities
  • dissemination of knowledge
  • align activities and share best practices

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