Cmc Dossier Leader

Sanofi

Framingham, MA, USA
Base: $148,500.00 - $214,500.00; bonus/equity: not...
Onsite
Cmc dossier preparation and development
Ai-powered solutions and digital tools
Lead cross-functional teams
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.
  • Enjoy a collaborative environment that values agility, innovation, and continuous improvement, with opportunities to grow talent and drive career.

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

  • CMC dossier preparation and development
  • AI-powered solutions and digital tools
  • Lead cross-functional teams
  • Regulatory submissions (IND/IMPD/CTN/IB/BP, BLA/NDA/MAA/JNDA)
  • Digital transformation and AI/ML applications

Nice-to-have

  • Agile/scrum methodologies
  • Cell/Gene Therapeutics experience
  • Data integration platforms
  • AI applications and prompt engineering

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