About this role
US Regulatory Strategy Lead at Sobi. Location: Waltham or United States or North America. Role: developing strategy, leading meetings, managing submissions Requirements: BS in a scientific discipline required, advanced degree preferred; 6+ years regulatory affairs experience with FDA meeting leadership and at least one major application (NDA/BLA) delivery; knowledge of GMP/GLP/GCP; strong communication and leadership. Category: Research and Development (R&D) Seniority: Senior Level Commitment: Full Time Workplace: Remote Languages: English