Associate Director, Regional Regulatory Lead-us

CSL Limited

King of Prussia, PA, USA
Base: $185,000 - $210,000; bonus/equity: incentive...
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Regional regulatory expertise
Health authority engagement
Regulatory strategy development
** CSL Limited is seeking an Associate Director, Regional Regulatory Lead-US with extensive regulatory experience in the biotech or pharmaceutical industry. The position, based in either King of Prussia, PA or Waltham, MA, is hybrid, requiring on-site work three days a week, and focuses on leading regulatory strategies and interactions with health authorities. **

Job Summary

  • CSL's R&D organization is accelerating innovation to deliver greater impact for patients.
  • You will be accountable for assigned product relationship with a health authority (FDA or EMA), ensuring alignment with product GRL.
  • The expected base salary range for this position at hiring is $185,000 - $210,000.

Matching Summary

Match Score: 75

** CSL Limited is seeking an Associate Director, Regional Regulatory Lead-US with extensive regulatory experience in the biotech or pharmaceutical industry. The position, based in either King of Prussia, PA or Waltham, MA, is hybrid, requiring on-site work three days a week, and focuses on leading regulatory strategies and interactions with health authorities. **

Salary

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

Skills & Requirements

Must-have

  • Regional regulatory expertise
  • Health authority engagement
  • Regulatory strategy development
  • Product lifecycle management

Nice-to-have

  • Patient-centric focus
  • Agile team environment
  • Cross-functional collaboration

Key Requirements

  • Bachelor's degree in life science
  • 10+ years biotech/pharma experience
  • 5+ years regulatory experience
  • 3+ years developmental product experience
  • Experience leading teams (preferred)
  • Knowledge of EU, US, Japan regulatory requirements
  • Direct agency interaction responsibility

Work Rights

Not specified

Tailored Resume

Cover Letter