Global Regulatory Strategist

Sanofi Consumer Healthcare

Morristown, NJ, US
Base: $148,500.00 - $214,500.00; bonus/equity: not...
8 years pharmaceutical industry experience
6 years regulatory affairs experience
Oncology therapeutic area expertise
The role involves developing regulatory product strategies for the oncology therapeutic area within an innovative global healthcare company

Job Summary

  • The role involves developing regulatory product strategies for the oncology therapeutic area within an innovative global healthcare company.
  • Candidates will lead submission teams to ensure timely filings for marketing applications and clinical trial milestones aligned with launch deadlines.
  • Sanofi offers a thoughtful rewards package including high-quality healthcare, wellness programs, and at least 14 weeks of gender-neutral parental leave.

Matching Summary

The role involves developing regulatory product strategies for the oncology therapeutic area within an innovative global healthcare company.

Salary

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

Skills & Requirements

Must-have

  • 8 years pharmaceutical industry experience
  • 6 years Regulatory Affairs experience
  • Oncology therapeutic area expertise
  • NDA/BLA/MAA submission leadership
  • IND/CTA clinical trial applications
  • Health Authority engagement planning

Nice-to-have

  • Experience with AI platforms in regulatory environment
  • Knowledge of Veeva Vault RIM or Plai systems
  • Strong cross-functional collaboration skills
  • Familiarity with expedited pathways like Fast Track
  • Multicultural and multinational environment sensitivity

Key Requirements

  • BS/BA in scientific discipline or MSc required
  • PharmD, PhD, MD, or DVM with 4 years experience alternative
  • Minimum 2 years Regulatory Affairs in oncology for advanced degree holders
  • US work authorization required based on location

Work Rights

Not specified

Tailored Resume

Cover Letter