Experienced Scientist, Cmc Regulatory Science

Johnson & Johnson

Beerse, Belgium
Cmc regulatory strategy alignment
Global dossier preparation
Health authority submissions
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 develops CMC content and dossier plans.
  • Contributes to the implementation of global CMC regulatory strategies and dossier plans by collaborating with other CMC RA personnel.

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
  • global dossier preparation
  • Health Authority submissions
  • CMC country specific documents
  • global submission plan oversight
  • responses to HA questions

Nice-to-have

  • patient-centric approach
  • innovative medicine development
  • cross-functional collaboration

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter