Senior Director, Global Regulatory Affairs, Pharmaceutical Partner And Cdx

Leica Biosystems

Deer Park, United States
Base: $200,000 - $270,000; bonus/equity: eligible ...
Fully remote
Global regulatory strategy development
Fda submission strategies
Regulatory intelligence and risk assessment
The Senior Director, Regulatory Affairs CDx Biopharma is responsible for shaping and executing regulatory strategies that enable accelerated growth in the U.S. CDx Pharma business

Job Summary

  • The Senior Director, Regulatory Affairs CDx Biopharma is responsible for shaping and executing regulatory strategies that enable accelerated growth in the U.S. CDx Pharma business.
  • This role requires close collaboration with the U.S.-based CDx Business Development team and pharmaceutical partners to deliver FDA-focused submission strategies for co-developed CDx products linked to drug approvals.
  • Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.

Matching Summary

The Senior Director, Regulatory Affairs CDx Biopharma is responsible for shaping and executing regulatory strategies that enable accelerated growth in the U.S. CDx Pharma business.

Salary

Base: $200,000 - $270,000; Bonus/Equity: eligible for bonus/incentive pay; Benefits: comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k)

Skills & Requirements

Must-have

  • Global regulatory strategy development
  • FDA submission strategies
  • Regulatory intelligence and risk assessment
  • Cross-functional program leadership
  • Regulatory authority engagement
  • CDx and Pharma product development

Nice-to-have

  • Continuous improvement and operational efficiency
  • Building high-caliber regulatory teams
  • Policy influence and industry forums
  • AI-driven diagnostics expertise

Key Requirements

  • 10+ years leadership experience in regulatory affairs
  • Advanced degree in a relevant Scientific background
  • Experience with high-complexity technologies like AI-enabled assays
  • Full accountability for timelines, budgets, and deliverables
  • Proven success in developing global regulatory strategies
  • Strong track record of leading global regulatory submissions

Work Rights

Not specified

Tailored Resume

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