Regulatory Strategist

Sanofi UK

Morristown, New Jersey, 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, to enable and drive the execution of aligned US, EU, and/or global regulatory strategy for assigned projects, including Health Authority (HA) interactions

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, to enable and drive the execution of aligned US, EU, and/or global regulatory strategy for assigned projects, including Health Authority (HA) interactions.
  • 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.
  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

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, to enable and drive the execution of aligned US, EU, and/or global regulatory strategy for assigned projects, including Health Authority (HA) interactions.

Salary

Base: $148,500.00 - $214,500.00; Bonus/Equity: Not specified; Benefits: 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
  • IND/CTA submission strategy
  • NDA/BLA/MAA/Extensions filings

Nice-to-have

  • Shape the future of medicine
  • Accelerate drug discovery and development
  • Flourish and grow your career
  • Chase the miracles of science
  • Pursue progress, discover extraordinary

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
  • HA meeting briefing documents preparation
  • Negotiating with national/regional HA
  • Multidisciplinary matrixed project teams experience
  • Project leadership experience

Work Rights

Not specified

Tailored Resume

Cover Letter