Cmc Dossier Leader

Sanofi Genzyme

Framingham, MA, US
Base: $148,500.00 - $214,500.00; bonus/equity: not...
Hybrid
Phd or ms in pharmaceutical drug development
Minimum 5 years cmc development experience
Proven track record authoring cmc dossiers
This role involves leading the preparation of CMC dossiers for regulatory submissions to enable advancement of product development through clinical phases to market authorization

Job Summary

  • This role involves leading the preparation of CMC dossiers for regulatory submissions to enable advancement of product development through clinical phases to market authorization.
  • The position requires leveraging cutting-edge digital tools and AI-powered solutions to transform how CMC regulatory documents are prepared and managed.
  • Sanofi offers a thoughtful rewards package including high-quality healthcare, wellness programs, and at least 14 weeks' gender-neutral parental leave.

Matching Summary

This role involves leading the preparation of CMC dossiers for regulatory submissions to enable advancement of product development through clinical phases to market authorization.

Salary

Base: $148,500.00 - $214,500.00; Bonus/Equity: Not specified; Benefits: Eligible for Company employee benefit programs

Skills & Requirements

Must-have

  • PhD or MS in pharmaceutical drug development
  • Minimum 5 years CMC development experience
  • Proven track record authoring CMC dossiers
  • Knowledge of CMC dossier structures for IND/NDA/MAA
  • Proficiency in Vault RIM, Word, and Adobe

Nice-to-have

  • Experience with agile/scrum methodologies
  • Advanced expertise in AI-powered document tools
  • Understanding of emerging digital technologies
  • Experience with data integration platforms
  • Knowledge of digital quality management systems

Key Requirements

  • PhD, MS, or university degree in pharmaceutical chemistry, pharmacy, or biochemistry
  • In-depth knowledge of pharmaceutical development
  • Leadership capabilities for cross-functional teams
  • Agility to embrace digital transformation and AI/ML applications

Work Rights

Not specified

Tailored Resume

Cover Letter