Associate Director, Regional Regulatory Lead-us

CSL Behring

King of Prussia, PA, USA
Base: $185,000 - $210,000; bonus/equity: incentive...
Hybrid
10+ years biotech or pharmaceutical experience
5+ years regulatory affairs experience
Direct fda or ema agency interaction
The role involves actively negotiating with health authorities like the FDA to achieve desired regional regulatory outcomes for assigned products

Job Summary

  • The role involves actively negotiating with health authorities like the FDA to achieve desired regional regulatory outcomes for assigned products.
  • Candidates will lead core document preparation and filing activities while ensuring alignment with global regulatory strategies and a patient-centric focus.
  • CSL Behring offers a hybrid work model requiring three days onsite per week within a dynamic biotech ecosystem committed to saving lives.

Matching Summary

The role involves actively negotiating with health authorities like the FDA to achieve desired regional regulatory outcomes for assigned products.

Salary

Base: $185,000 - $210,000; Bonus/Equity: Incentive compensation and equity included; Benefits: Comprehensive benefits package available

Skills & Requirements

Must-have

  • 10+ years biotech or pharmaceutical experience
  • 5+ years regulatory affairs experience
  • Direct FDA or EMA agency interaction
  • Leading developmental product submissions
  • Module 1 documentation preparation

Nice-to-have

  • Experience leading teams in matrix environment
  • Knowledge of EU, US, and Japan regulations
  • Advanced degree in life sciences or MBA
  • Fostering collaborative team environment
  • Strategic risk assessment capabilities

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 experience working on developmental products
  • Prior experience managing teams as direct or matrix manager
  • Demonstrated knowledge of multi-region regulatory requirements

Work Rights

Not specified

Tailored Resume

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