Jobs 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.

Lead cross-functional project management for pharmaceutical product launches, building and maintaining integrated Smartsheet plans, identifying and mitigating risks, communicating status to stakeholders and senior leadership, and driving operational excellence and continuous improvement to ensure on-time commercialization.

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.

Lead a regional hematology commercial team to achieve sales goals, coach and develop field staff, execute launch and market strategies, collaborate cross-functionally, track KPIs, ensure regulatory compliance, and drive customer and product performance across the Mid-Atlantic region.

Lead global regulatory advertising & promotion strategy and the AdPromo team, own the global material review process, manage FDA OPDP/APLB interactions, provide regulatory advice across product lifecycle, develop SOPs, train stakeholders, and ensure compliant, timely promotional and corporate communications for Sobi products.