10+ years biotech or pharmaceutical industry experience
5+ years regulatory experience with developmental products
Direct interaction responsibility with fda or ema
This role involves leveraging regional regulatory expertise to influence global integrated regulatory strategies for assigned products with a patient-centric focus
Job Summary
This role involves leveraging regional regulatory expertise to influence global integrated regulatory strategies for assigned products with a patient-centric focus.
The successful candidate will actively negotiate with health authorities like the FDA to achieve desired outcomes while ensuring timely delivery of regulatory filings.
CSL offers a hybrid work model requiring three days onsite per week in either King of Prussia, PA or Waltham, MA.
Matching Summary
This role involves leveraging regional regulatory expertise to influence global integrated regulatory strategies for assigned products with a patient-centric focus.
Salary
Base: $185,000 - $210,000; Bonus/Equity: Incentive compensation and equity included; Benefits: Not specified
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
Bachelor's degree in life science required
Nice-to-have
Advanced degree in related field preferred
Experience leading teams as direct or matrix manager
Knowledge of EU, US, and Japan regulatory requirements
Strong collaborative team environment fostering
Key Requirements
10+ years industry experience
5+ years regulatory experience
3 years working on developmental products
Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or clinical medicine