Associate Director, Regional Regulatory Lead-us

CSL Behring

King of Prussia, Pennsylvania, United States
Base: $185,000 - $210,000; bonus/equity: incentive...
Hybrid (3 days onsite)
10+ years biotech or pharma experience
5+ years regulatory experience
3 years developmental product experience
CSL Behring is seeking an Associate Director, Regional Regulatory Lead for their offices in King of Prussia, PA or Waltham, MA. This hybrid position requires extensive regulatory experience in the biotech or pharmaceutical industry, focusing on collaboration and patient-centric strategies to ensure successful regulatory outcomes

Job Summary

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

Matching Summary

Match Score: 85

CSL Behring is seeking an Associate Director, Regional Regulatory Lead for their offices in King of Prussia, PA or Waltham, MA. This hybrid position requires extensive regulatory experience in the biotech or pharmaceutical industry, focusing on collaboration and patient-centric strategies to ensure successful regulatory outcomes.

Salary

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

Skills & Requirements

Must-have

  • 10+ years biotech or pharma experience
  • 5+ years regulatory experience
  • 3 years developmental product experience
  • Direct FDA interaction responsibility
  • Team leadership in matrix environment

Nice-to-have

  • Advanced degree in life sciences or MBA
  • Experience with EU and Japan regions
  • Fostering collaborative team environment
  • Strategic risk-taking capabilities

Key Requirements

  • Bachelor's degree in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science
  • 10+ years experience in biotech/pharma industry
  • At least 5 years of regulatory experience
  • 3 years working on developmental products
  • 3 years leading teams as direct or matrix manager

Work Rights

Not specified

Tailored Resume

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