Regulatory Strategist

Sanofi

Morristown, NJ, US
Base: $148,500.00 - $214,500.00; bonus/equity: not...
Onsite
Global regulatory strategy definition
Us, eu, global regulatory strategy execution
Health authority interactions
As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their regulatory expertise to contribute to the definition of the global regulatory strategy

Job Summary

  • As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their regulatory expertise to contribute to the definition of the global regulatory strategy.
  • The RS provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
  • Sanofi offers endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

Matching Summary

As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their regulatory expertise to contribute to the definition of the global regulatory strategy.

Salary

Base: $148,500.00 - $214,500.00; Bonus/Equity: Not specified; Benefits: Employees may be eligible to participate in Company employee benefit programs.

Skills & Requirements

Must-have

  • Global regulatory strategy definition
  • US, EU, global regulatory strategy execution
  • Health Authority interactions
  • Regulatory CMC not directly applicable
  • NDA/BLA/MAA/Extensions filings
  • IND/CTA submission strategy

Nice-to-have

  • Contribute to Target Product Profile
  • Lead GRT meetings
  • Cross-functional team collaboration
  • Project leadership experience

Key Requirements

  • BS/BA degree in a relevant scientific discipline
  • At least 6 years pharmaceutical/biotechnology experience
  • At least 4 years Regulatory Affairs experience
  • Experience with sBLA/sNDA/MAA, INDs/CTAs
  • Experience with HA meeting briefing documents
  • Negotiating with national/regional HA
  • Experience on multidisciplinary matrixed project teams

Work Rights

Not specified

Tailored Resume

Cover Letter