Regulatory Strategist

Sanofi

Morristown, NJ, US
Base: $148,500.00 - $214,500.00; bonus/equity: not...
Onsite
6 years pharmaceutical experience
4 years regulatory affairs experience
Preparation of bla nda maa filings
The role involves shaping the future of medicine by accelerating drug discovery and development to find answers for patients

Job Summary

  • The role involves shaping the future of medicine by accelerating drug discovery and development to find answers for patients.
  • Responsibilities include contributing to the Global Regulatory Project Strategy and ensuring alignment with core product labeling for lifecycle management.
  • Sanofi offers a thoughtful rewards package including high-quality healthcare and at least 14 weeks' gender-neutral parental leave.

Matching Summary

The role involves shaping the future of medicine by accelerating drug discovery and development to find answers for patients.

Salary

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

Skills & Requirements

Must-have

  • 6 years pharmaceutical experience
  • 4 years Regulatory Affairs experience
  • Preparation of BLA NDA MAA filings
  • IND CTA submission strategy
  • Health Authority engagement planning

Nice-to-have

  • Project leadership experience preferred
  • Multidisciplinary matrixed team experience
  • Negotiating with national regional HA
  • Experience with multiple modalities
  • Leading GRT meetings

Key Requirements

  • BS/BA in scientific discipline required
  • Advanced degree (PharmD PhD MD) preferred
  • At least 6 years relevant pharma/biotech experience
  • At least 4 years Regulatory Affairs experience
  • US work authorization required

Work Rights

Not specified

Tailored Resume

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