CSL is seeking an Associate Director, Regional Regulatory Lead-US for their offices in King of Prussia, PA, or Waltham, MA. This hybrid role focuses on leveraging regional regulatory expertise to influence global regulatory strategies for biotherapeutic products, ensuring timely and successful regulatory outcomes
Job Summary
CSL's R&D organization is accelerating innovation to deliver greater impact for patients.
You will be accountable for assigned product relationship with a health authority (FDA or EMA), ensuring alignment with product GRL.
The expected base salary range for this position at hiring is $185,000 - $210,000.
Matching Summary
Match Score: 85
CSL is seeking an Associate Director, Regional Regulatory Lead-US for their offices in King of Prussia, PA, or Waltham, MA. This hybrid role focuses on leveraging regional regulatory expertise to influence global regulatory strategies for biotherapeutic products, ensuring timely and successful regulatory outcomes.
Salary
Base: $185,000 - $210,000; Bonus/Equity: Incentive compensation and equity may be included; Benefits: Not specified
Skills & Requirements
Must-have
Regional regulatory expertise
Health authority engagement
Regulatory strategy development
Product filing preparation
Bi-directional communication
Nice-to-have
Patient-centric focus
Agile team environment
Collaborative culture
Risk assessment and decision making
Key Requirements
Bachelor's degree in life science
10+ years biotech/pharma experience
5+ years regulatory experience
3+ years developmental product experience
Experience leading teams
Knowledge of multiple key region regulatory requirements