Associate Director, Regional Regulatory Lead-us

CSL Behring

King of Prussia, Pennsylvania, United States
Base: $185,000 - $210,000; bonus/equity: incentive...
Hybrid
10+ years biotech or pharmaceutical experience
5+ years regulatory experience
3 years developmental product experience
The role involves leveraging regional regulatory expertise to influence global strategies for assigned products with a patient-centric focus

Job Summary

  • The role involves leveraging regional regulatory expertise to influence global strategies for assigned products with a patient-centric focus.
  • Candidates will actively negotiate with health authorities like the FDA to achieve desired regulatory outcomes for developmental and marketed products.
  • CSL offers a hybrid work model requiring three days onsite per week in either King of Prussia, PA or Waltham, MA.

Matching Summary

The role involves leveraging regional regulatory expertise to influence global strategies for assigned products with a patient-centric focus.

Salary

Base: $185,000 - $210,000; Bonus/Equity: Incentive compensation and equity included; Benefits: Not specified

Skills & Requirements

Must-have

  • 10+ years biotech or pharmaceutical experience
  • 5+ years regulatory experience
  • 3 years developmental product experience
  • Direct FDA or EMA agency interaction
  • Leading cross-functional regulatory teams

Nice-to-have

  • Advanced degree in life sciences or MBA
  • Experience in EU, US, and Japan regions
  • Matrix management leadership skills
  • Patient-centric regulatory vision
  • Collaborative team environment fostering

Key Requirements

  • Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or clinical medicine
  • 10+ years industry experience with 5+ years in regulatory affairs
  • 3+ years leading teams as direct or matrix manager
  • Knowledge of regulatory requirements in multiple key regions

Work Rights

Not specified

Tailored Resume

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