Associate Director, Regional Regulatory Lead-us

CSL Behring

King of Prussia, Pennsylvania, United States
Base: $185,000 - $210,000; bonus/equity: incentive...
Hybrid (onsite three days a week)
10+ years biotech or pharmaceutical industry experience
5+ years regulatory experience with developmental products
Direct interaction responsibility with fda or ema
CSL Behring is seeking an Associate Director, Regional Regulatory Lead-US, to enhance their regulatory strategy within the biotech sector. This hybrid role requires extensive regulatory experience and interaction with health authorities, focusing on the delivery of innovative therapies

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 and lead core document preparation.
  • CSL Behring offers a hybrid work model requiring three days onsite per week in either King of Prussia, PA or Waltham, MA.

Matching Summary

Match Score: 85

CSL Behring is seeking an Associate Director, Regional Regulatory Lead-US, to enhance their regulatory strategy within the biotech sector. This hybrid role requires extensive regulatory experience and interaction with health authorities, focusing on the delivery of innovative therapies.

Salary

Base: $185,000 - $210,000; Bonus/Equity: Incentive compensation and equity included; Benefits: Comprehensive well-being support detailed on company website

Skills & Requirements

Must-have

  • 10+ years biotech or pharmaceutical industry experience
  • 5+ years regulatory experience with developmental products
  • Direct interaction responsibility with FDA or EMA

Nice-to-have

  • Experience leading teams in matrix environments
  • Advanced degree in life sciences or MBA preferred
  • Knowledge of EU, US, and Japan regulatory requirements

Key Requirements

  • Bachelor's degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related field
  • Minimum 10 years total industry experience
  • At least 3 years of team leadership experience

Work Rights

Not specified

Tailored Resume

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