Regulatory Affairs Operations

Mayoly

**
Gracs digital strategy projects
Regulatory information management systems
Veeva platform experience
** Mayoly is seeking a Regulatory Affairs Operations professional to support the implementation of Global Regulatory Affairs, Compliance, and Safety (GRACS) Digital Strategy projects. The role involves collaboration with various stakeholders to enhance regulatory information management systems, ensuring regional needs are met while providing training and support to system users. **

Job Summary

  • The Regulatory Affairs Operations role supports regional implementation and enhancement of Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems.
  • This position involves partnering with various departments to ensure successful regional implementation of GRACS Regulatory systems and supporting continuous improvements.
  • Key responsibilities include user support, data quality evaluation, regional needs representation in global projects, and potential involvement in regional projects leveraging change management and business process development skills.

Matching Summary

Match Score: 75

** Mayoly is seeking a Regulatory Affairs Operations professional to support the implementation of Global Regulatory Affairs, Compliance, and Safety (GRACS) Digital Strategy projects. The role involves collaboration with various stakeholders to enhance regulatory information management systems, ensuring regional needs are met while providing training and support to system users. **

Skills & Requirements

Must-have

  • GRACS Digital Strategy projects
  • Regulatory information management systems
  • Veeva platform experience
  • Cross-functional team leadership
  • Business process development

Nice-to-have

  • Adapt procedures to regional needs
  • Continuous system enhancements
  • Automation-based solutions
  • Global regulatory training facilitation
  • Share best practices with colleagues

Key Requirements

  • 2-4 years experience in Regulatory Affairs/Operations/pharma manufacturing
  • 3+ years implementing/supporting regulatory information systems
  • Bachelor's degree in science, IT, or Pharmacy
  • Demonstrated Veeva platform experience
  • Experience with project management methodologies
  • Experience with change management

Work Rights

Not specified

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