Cmc Dossier Leader

Sanofi

Framingham, MA, US
Base: $148,500.00 - $214,500.00; bonus/equity: not...
Onsite
Ai-powered solutions and digital tools
Cmc dossier preparation and development
Lead cmc sub team
Drive AI-powered solutions and digital tools to transform how we prepare CMC regulatory documents

Job Summary

  • Drive AI-powered solutions and digital tools to transform how we prepare CMC regulatory documents.
  • Lead, coordinate, and manage CMC dossier preparation and development processes, ensuring timely delivery for regulatory submissions.
  • Play an instrumental part in developing best practices and digital innovation within the CMC community.

Matching Summary

Drive AI-powered solutions and digital tools to transform how we prepare CMC regulatory documents.

Salary

Base: $148,500.00 - $214,500.00; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • AI-powered solutions and digital tools
  • CMC dossier preparation and development
  • Lead CMC sub team
  • Regulatory submissions (IND/IMPD/CTN/IB/BP, BLA/NDA/MAA/JNDA)
  • Pharmaceutical development for Biologics

Nice-to-have

  • Agile/scrum methodologies
  • AI/ML applications in pharma
  • Digital quality management systems
  • Cell/Gene Therapeutics experience

Key Requirements

  • 5+ years of professional experience in CMC development
  • Proven track record in authoring CMC dossiers
  • MS or PHD or equivalent degree in life sciences
  • Excellent oral and written English communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter