Teams at Sobi

Lead US regulatory strategy for assigned development and marketed products: develop risk-mitigating regulatory plans, represent Regulatory on cross-functional teams, prepare and lead major FDA meetings, manage responses to FDA information requests, contribute to IND/NDA/BLA submissions and labeling, liaise with consultants and partners, monitor US regulatory landscape, and champion expedited pathways to accelerate patient access.

Lead North America launch excellence by establishing a repeatable launch framework, orchestrating cross-functional readiness, governance, KPIs and risk management. Drive integrated project plans, milestone tracking, analytics-informed decisions, continuous improvement, and executive communication to ensure on-time, high-quality commercialization of pipeline products in rare disease markets.

Lead US regulatory strategy for assigned development and marketed products, represent Regulatory on cross-functional teams, prepare and lead FDA meetings, manage IND/NDA/BLA submissions, assess regulatory risk and expedited pathways, liaise with FDA and consultants, and contribute to labeling and regulatory compliance.