Gra Cmc Lead

Sanrafaelvet

Morristown, NJ, US
Base: $122,250.00 - $176,583.33; bonus/equity: not...
Onsite
Global cmc regulatory strategy
Health authority interactions
Portfolio management of vaccine projects
As a GRA CMC Lead, you will be responsible for managing a portfolio of vaccine projects and defining global CMC regulatory strategies in collaboration with multiple internal and external stakeholders

Job Summary

  • As a GRA CMC Lead, you will be responsible for managing a portfolio of vaccine projects and defining global CMC regulatory strategies in collaboration with multiple internal and external stakeholders.
  • Sanofi offers a supportive, future-focused team environment with opportunities for career growth, a comprehensive rewards package, and extensive health and wellbeing benefits including at least 14 weeks’ gender-neutral parental leave.
  • The role involves direct interactions with major Health Authorities such as the FDA and EMA, ensuring regulatory compliance and successful negotiation of strategic decisions.

Matching Summary

As a GRA CMC Lead, you will be responsible for managing a portfolio of vaccine projects and defining global CMC regulatory strategies in collaboration with multiple internal and external stakeholders.

Salary

Base: $122,250.00 - $176,583.33; Bonus/Equity: Not specified; Benefits: Company employee benefit programs available

Skills & Requirements

Must-have

  • Global CMC regulatory strategy
  • Health Authority interactions
  • Portfolio management of vaccine projects
  • Change control assessment
  • Cross-functional collaboration
  • Regulatory submission coordination

Nice-to-have

  • AI-powered biopharma environment
  • Strategic negotiation support
  • Representation in external programs
  • Initiative and effective communication
  • Risk assessment and mitigation

Key Requirements

  • At least 4+ years regulatory experience
  • Experience in Regulatory CMC department
  • Knowledge of global regulations and guidelines
  • BS/BA degree in relevant scientific discipline
  • Advanced degree preferred (PharmD, PhD, MD, DVM, MSc)
  • US or Puerto Rico residency required

Work Rights

US or Puerto Rico residency required

Tailored Resume

Cover Letter