Responsible for all aspects of the US Regulatory Strategy for assigned development and marketed products
Core member of the Global Regulatory Team (GRT) providing US-focused product strategy
Points of contact within GRA on the core asset team (CAT) and Medicines Development Team (MDT)
Ensures guidance on regulatory pathways to accelerate product development is evaluated and included
Prepares cross-functional team for major FDA Meetings and leads/facilitates major meetings with the Agency
Contributes to Submission Taskforce meeting and efforts to ensure timely and quality submissions

BS in a scientific discipline
Advanced degree (PhD, PharmD, MD) preferred but not required
6+ years regulatory affairs experience having led health authority meetings (FDA)
Ideal candidate will have delivered at least one major application (NDA/BLA or sNDA/sBLA)
Experience with immunology late-stage development/marketed products ideal but not required
Great leadership skills with high emotional intelligence
Must be a great team player with strong verbal and written communication skills

Regulatory Strategy Lead

Key skills