10+ years biotech or pharmaceutical industry experience
5+ years regulatory experience with developmental products
Direct interaction responsibility with fda or ema
The role involves actively negotiating with health authorities like the FDA to achieve desired regional regulatory outcomes for assigned products
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 ensuring alignment with global regulatory strategies and a patient-centric focus.
CSL Behring offers a hybrid work model requiring three days onsite per week in either King of Prussia, PA or Waltham, MA.
Matching Summary
The role involves actively negotiating with health authorities like 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: 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
Experience leading teams in matrix or direct management
Knowledge of EU, US, and Japan regulatory requirements
Nice-to-have
Advanced degree in life sciences or MBA preferred
Fostering collaborative and empowered team environment
Ability to leverage regional commercial insights
Prudent risk-taking for timely regulatory outcomes
Key Requirements
Bachelor's degree in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science
10+ years experience in biotech or pharmaceutical industry
At least 5 years of regulatory experience including 3 years on developmental products
3+ years experience leading teams as direct or matrix manager