CSL's R&D organization is accelerating innovation to deliver greater impact for patients and is committed to developing therapies that make a meaningful difference worldwide
Job Summary
CSL's R&D organization is accelerating innovation to deliver greater impact for patients and is committed to developing therapies that make a meaningful difference worldwide.
The Associate Director, Regional Regulatory Lead-US is accountable for assigned product relationships with health authorities and leads regional regulatory activities to ensure timely delivery of successful regulatory outcomes.
CSL Behring is a global biotherapeutics leader focused on innovative therapies and inclusion, fostering a diverse workforce and strong stakeholder relationships.
Matching Summary
CSL's R&D organization is accelerating innovation to deliver greater impact for patients and is committed to developing therapies that make a meaningful difference worldwide.
Skills & Requirements
Must-have
Regulatory affairs leadership
Health authority interaction
Regional regulatory strategy
Product filing preparation
Risk assessment and decision making
Bi-directional communication with commercial operations
Nice-to-have
Team leadership and accountability
Collaborative and empowered team environment
Patient-centric regulatory focus
Competitive regulatory intelligence
Hybrid work environment
Key Requirements
Bachelor’s degree in life sciences
10+ years biotech/pharmaceutical experience
5+ years regulatory experience
3+ years developmental product regulatory experience
Experience leading teams
Knowledge of multiple key regions' regulatory requirements