Exp. Scientist, Cmc Regulatory Science

Johnson & Johnson

Allschwil, Basel-Country, Switzerland
Cmc regulatory strategy
Global dossiers/variations
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.
  • 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
  • global dossiers/variations
  • Health Authority submissions
  • CMC country specific documents
  • global submission plan timing
  • responses to HA questions

Nice-to-have

  • patient-centric approach
  • driving customer value
  • challenging the status quo

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter