Exp. Scientist, Cmc Regulatory Science

Johnson & Johnson

Allschwil, Basel-Country, Switzerland
Not specified
Cmc regulatory strategy alignment
Global dossier preparation
Submission to health authorities
Johnson & Johnson is seeking an Experienced Scientist in CMC Regulatory Science to support regulatory activities in the Chemistry, Manufacturing, and Controls area. The position emphasizes collaboration within teams to align regulatory strategies with global objectives

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.
  • Under the supervision/collaboration of more senior CMC RA personnel develops CMC content and dossier plans.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking an Experienced Scientist in CMC Regulatory Science to support regulatory activities in the Chemistry, Manufacturing, and Controls area. The position emphasizes collaboration within teams to align regulatory strategies with global objectives.

Skills & Requirements

Must-have

  • CMC regulatory strategy alignment
  • global dossier preparation
  • submission to Health Authorities
  • CMC country specific documents
  • global submission plan oversight
  • responses to HA questions

Nice-to-have

  • proactively senses and responds
  • delivers results that meet expectations
  • makes decisions based on facts
  • challenges the status quo

Key Requirements

  • Minimum 1 year of experience
  • University degree in engineering, biological, pharmaceutical, or chemical sciences
  • Prior experience in drug development, analytical development or manufacturing preferred
  • Regulatory experience within this scope encouraged
  • Experience with global CMC regulatory procedures and guidelines/requirements
  • Experience in working in project teams and/or a matrix organization
  • Excellent oral and written communication skills
  • Ability to work successfully within a collaborative team environment

Work Rights

Not specified

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