Associate Director, Regional Regulatory Lead-us

CSL Behring

King of Prussia, PA, USA
Base: $185,000 - $210,000; bonus/equity: incentive...
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10+ years biotech or pharmaceutical experience
5+ years regulatory experience
Direct fda interaction responsibility
** CSL Behring is seeking an Associate Director, Regional Regulatory Lead for their King of Prussia, PA, or Waltham, MA offices, offering a hybrid work model. The role involves overseeing regulatory activities and interactions with health authorities to ensure successful product outcomes, requiring significant experience in biotech or pharmaceuticals. **

Job Summary

  • The role involves actively negotiating with health authorities like the FDA to achieve desired regional regulatory outcomes for assigned products.
  • Candidates will lead core document preparation and filing activities while fostering a collaborative team environment within an agile R&D structure.
  • CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies delivered via plasma fractionation and recombinant protein technology.

Matching Summary

Match Score: 75

** CSL Behring is seeking an Associate Director, Regional Regulatory Lead for their King of Prussia, PA, or Waltham, MA offices, offering a hybrid work model. The role involves overseeing regulatory activities and interactions with health authorities to ensure successful product outcomes, requiring significant experience in biotech or pharmaceuticals. **

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
  • Direct FDA interaction responsibility
  • Leading developmental product teams
  • Module 1 documentation preparation

Nice-to-have

  • Advanced degree in life sciences or MBA
  • Experience leading matrix management teams
  • Knowledge of EU and Japan regulatory requirements
  • Strategic risk assessment capabilities
  • Patient-centric focus in regulatory strategy

Key Requirements

  • Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or clinical medicine
  • Minimum 10 years industry experience with 5 years in regulatory affairs
  • 3 years experience working on developmental products
  • 3 years experience leading teams as direct or matrix manager
  • Knowledge of regulatory requirements in multiple key regions including EU, US, and Japan

Work Rights

Not specified

Tailored Resume

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