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 negotiate with health authorities like the FDA to achieve desired regulatory outcomes for developmental and marketed products.
CSL Behring offers a hybrid work model requiring three days onsite per week in King of Prussia, PA or Waltham, MA.
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: Not specified
Skills & Requirements
Must-have
10+ years biotech or pharmaceutical experience
5+ years regulatory experience
Direct FDA or EMA interaction
Leading teams in matrix environment
Knowledge of EU, US, Japan regulations
Nice-to-have
Advanced degree in life sciences or MBA
Experience with developmental products
Strong negotiation skills with health authorities
Patient-centric focus in strategy
Collaborative team environment
Key Requirements
Bachelor's degree in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science
10+ years industry experience with 5+ years in regulatory affairs
3+ years leading teams as direct or matrix manager