Experienced Scientist, Cmc Regulatory Science

Johnson & Johnson Innovative Medicine

Beerse, Belgium
Cmc regulatory strategy alignment
Cmc content and dossier development
Global dossier preparation and submission
The Experienced Scientist Regulatory is responsible for supporting team members for a broad range of regulatory activities in the Chemistry, Manufacturing and Controls area of Global Regulatory Affairs

Job Summary

  • The Experienced Scientist Regulatory is responsible for supporting team members for a broad range of regulatory activities in the Chemistry, Manufacturing and Controls area of Global Regulatory Affairs.
  • Assists in ensuring the CMC regulatory strategy is in alignment with the global/regional/commercial regulatory strategy and contributes to the implementation of global CMC regulatory strategies.
  • Works with other CMC RA personnel to manage and resolve any issues, and escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance, and continued lifecycle management of the product.

Matching Summary

The Experienced Scientist Regulatory is responsible for supporting team members for a broad range of regulatory activities in the Chemistry, Manufacturing and Controls area of Global Regulatory Affairs.

Skills & Requirements

Must-have

  • CMC regulatory strategy alignment
  • CMC content and dossier development
  • Global dossier preparation and submission
  • CMC country specific document management
  • Global submission plan oversight
  • Responses to Health Authority questions

Nice-to-have

  • Proactive problem sensing
  • Customer value focus
  • Fact-based decision making
  • Challenging the status quo

Key Requirements

  • Minimum 1 year of experience
  • University degree in relevant science field
  • Prior experience in drug development preferred
  • Experience with global CMC regulatory procedures
  • Experience in project teams/matrix organization

Work Rights

Not specified

Tailored Resume

Cover Letter