Quality Intelligence & Advocacy Lead

sanofi

Morristown, NJ, US
Base: $161,250.00 - $232,916.66; bonus/equity: not...
Onsite
Gxp regulatory compliance
Quality systems implementation
Regulatory surveillance and benchmarking
This role influences the development of external regulations and drives Sanofi's compliance with international GxP standards across multiple product portfolios

Job Summary

  • This role influences the development of external regulations and drives Sanofi's compliance with international GxP standards across multiple product portfolios.
  • The position requires engagement with senior leadership, regulatory authorities, and trade associations to align advocacy priorities and represent Sanofi externally.
  • Sanofi offers a supportive, future-focused team environment with comprehensive health and wellbeing benefits, including at least 14 weeks of gender-neutral parental leave.

Matching Summary

This role influences the development of external regulations and drives Sanofi's compliance with international GxP standards across multiple product portfolios.

Salary

Base: $161,250.00 - $232,916.66; Bonus/Equity: Not specified; Benefits: Employee benefit programs available

Skills & Requirements

Must-have

  • GxP regulatory compliance
  • Quality Systems implementation
  • Regulatory surveillance and benchmarking
  • Engagement with regulatory authorities
  • Cross-functional stakeholder collaboration
  • Data-driven quality insights

Nice-to-have

  • Industry association membership
  • Experience authoring guidance documents
  • French language skills
  • AI and digital technology knowledge
  • International regulatory experience

Key Requirements

  • 9+ years pharmaceutical or biotech experience
  • Experience with global regulatory authorities
  • Knowledge of ICH guidelines revision process
  • Strong understanding of manufacturing and validation
  • Master’s degree or PhD preferred
  • Auditor and/or inspector experience
  • US work authorization required

Work Rights

US and Puerto Rico residents only

Tailored Resume

Cover Letter