Associate Director, Regional Regulatory Lead-us

CSL Behring

King of Prussia, PA, USA
Base: $185,000 - $210,000; bonus/equity: incentive...
Hybrid
10+ years biotech or pharmaceutical industry experience
5+ years regulatory experience with developmental products
Direct interaction responsibility with fda or ema
The role involves leveraging regional regulatory expertise to influence global strategies for assigned products with a patient-centric focus

Job Summary

  • The role involves leveraging regional regulatory expertise to influence global strategies for assigned products with a patient-centric focus.
  • Candidates will actively engage with health authorities like the FDA to drive positive regulatory outcomes and lead core document preparation.
  • CSL is an equal opportunity employer committed to inclusion and belonging, offering a hybrid work model with onsite requirements.

Matching Summary

The role involves leveraging regional regulatory expertise to influence global strategies for assigned products with a patient-centric focus.

Salary

Base: $185,000 - $210,000; Bonus/Equity: Incentive compensation and equity included; Benefits: Comprehensive benefits package described as supporting well-being

Skills & Requirements

Must-have

  • 10+ years biotech or pharmaceutical industry experience
  • 5+ years regulatory experience with developmental products
  • Direct interaction responsibility with FDA or EMA
  • Experience leading teams in matrix or direct management
  • Knowledge of EU, US, and Japan regulatory requirements

Nice-to-have

  • Advanced degree in pharmacy, biology, or related field
  • MBA or PhD preferred for senior roles
  • Fostering collaborative and empowered team environment
  • Ability to negotiate on behalf of the company
  • Strategic risk-taking for timely regulatory outcomes

Key Requirements

  • Bachelor's degree in life sciences required
  • 10+ years total industry experience
  • 5+ years specific regulatory experience
  • 3+ years leading teams
  • Experience with developmental products

Work Rights

Not specified

Tailored Resume

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