Associate Director, Regional Regulatory Lead-us

CSL SEQIRUS

King of Prussia, Pennsylvania, United States
Base: $185,000 - $210,000; bonus/equity: incentive...
Hybrid
10+ years biotech or pharma experience
5+ years regulatory experience
Direct fda interaction responsibility
The role involves actively negotiating with the FDA to achieve desired regional regulatory outcomes for assigned products

Job Summary

  • The role involves actively negotiating with the FDA to achieve desired regional regulatory outcomes for assigned products.
  • Candidates will lead core document preparation and health authority engagements while ensuring alignment with global strategies.
  • CSL offers a hybrid work model requiring three days onsite per week in King of Prussia, PA or Waltham, MA.

Matching Summary

The role involves actively negotiating with 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 described on company website

Skills & Requirements

Must-have

  • 10+ years biotech or pharma experience
  • 5+ years regulatory experience
  • Direct FDA interaction responsibility
  • Leading developmental product teams
  • Module 1 documentation expertise

Nice-to-have

  • Advanced degree in life sciences
  • Experience with EU and Japan regions
  • Matrix management leadership skills
  • Strategic risk assessment capabilities
  • Patient-centric regulatory vision

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 leading teams as direct or matrix manager
  • Knowledge of regulatory requirements in US, EU, and Japan
  • Direct agency interaction experience with at least one health authority

Work Rights

Not specified

Tailored Resume

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