Global Regulatory Affairs (gra) Chemistry, Manufacturing And Controls (cmc) Cmc Lead

Sanofi

Morristown, NJ, USA
$148,500.00 - $214,500.00; not specified; not spec...
Hybrid
Global regulatory strategies
Pharmaceutical and vaccine products
Health authority negotiations
As GRA CMC Lead within our GRA CMC & GRA Device Organization, you’ll drive global regulatory strategies for pharmaceutical and vaccine products, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence the success of drug approvals through strategic negotiations with health authorities worldwide

Job Summary

  • As GRA CMC Lead within our GRA CMC & GRA Device Organization, you’ll drive global regulatory strategies for pharmaceutical and vaccine products, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence the success of drug approvals through strategic negotiations with health authorities worldwide.
  • Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role offers the opportunity to drive regulatory strategy for pharmaceutical products and vaccines across their lifecycle.
  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Matching Summary

As GRA CMC Lead within our GRA CMC & GRA Device Organization, you’ll drive global regulatory strategies for pharmaceutical and vaccine products, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence the success of drug approvals through strategic negotiations with health authorities worldwide.

Salary

$148,500.00 - $214,500.00; Not specified; Not specified

Skills & Requirements

Must-have

  • global regulatory strategies
  • pharmaceutical and vaccine products
  • health authority negotiations
  • CMC regulatory experience
  • responding to Health Authority questions

Nice-to-have

  • AI-powered research
  • deep immunoscience
  • innovative therapies
  • supportive, inclusive environment

Key Requirements

  • 6+ years CMC regulatory experience
  • Bachelor's degree in scientific discipline
  • Experience preparing regulatory documentation
  • Familiarity with standard submission processes
  • Understanding of pharmaceutical development
  • Ability to work effectively in a matrix environment

Work Rights

Not specified

Tailored Resume

Cover Letter