Teams at Sobi

Lead US regulatory strategy for assigned development and marketed products. Serve as US point of contact with FDA, prepare and lead major meetings, develop risk/mitigation plans, drive use of expedited pathways, support IND/NDA/BLA submissions, collaborate cross-functionally and with consultants, and monitor US regulatory environment.

Lead international cross-functional CMC and technical operations teams to deliver Module 3 NDA documentation. Manage program plans, timelines, budgets, risks, document reviews, governance presentations, and vendor/CMO interactions to ensure on-time, on-budget regulatory submissions.

Serve as primary customer contact to drive sales and execute marketing strategy for hematology biologics. Provide clinical product knowledge, develop territory business plans, meet/exceed sales targets, represent Sobi at local meetings, manage specialty pharmacy and reimbursement processes, report adverse events, and complete required administrative duties.