Associate Director, Regional Regulatory Lead-us

CSL

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

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

Match Score: 85

CSL is seeking an Associate Director, Regional Regulatory Lead for their offices in King of Prussia, PA, or Waltham, MA. This hybrid role requires significant regulatory experience in the biotech or pharmaceutical industry, focusing on collaboration and strategic regulatory leadership to ensure successful product outcomes.

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 experience
  • 3 years developmental product experience
  • Direct FDA or EMA interaction responsibility
  • Team leadership in matrix environment

Nice-to-have

  • Advanced degree in life sciences or MBA
  • Experience with EU, US, and Japan regions
  • Fostering collaborative empowered team culture
  • Strategic risk-taking abilities

Key Requirements

  • Bachelor's degree in pharmacy, biology, chemistry, pharmacology, clinical medicine or related field
  • Master's, PhD, MD, DVM or MBA preferred
  • Minimum 10 years industry experience with 5 years in regulatory affairs
  • Proven track record leading teams for at least 3 years

Work Rights

Not specified

Tailored Resume

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