Senior Director, Regulatory Affairs Strategy - Cell Therapy

Role: Lead global regulatory strategy for pioneering cell therapy programs across indications such as cancer, immune-mediated, and rare diseases, guiding programs from current stage through BLA submission with a focus on efficient approval pathways and competitive labeling. Responsibilities: develop and execute end-to-end regulatory strategies, lead health authority engagements, oversee dossier and labeling strategies, collaborate with cross-functional teams (clinical, CMC, safety, commercial), and manage regulatory milestones and risk assessments. Lead and mentor a global regulatory team, build external relationships with authorities, and innovate regulatory tools. Maintain product compliance for marketed brands. Qualifications: Bachelor's degree in a science field; 7+ years in regulatory affairs with proven success in cell therapy and complex biologics development; deep understanding of global regulatory science, drug/biologic development, and experience in oncology, autoimmune, or rare disease areas. Skills: strategic thinking, stakeholder management, experience leading health authority interactions, excellent communication, and team leadership. High-Value: Cell therapy, oncology/autoimmune/rare diseases, development from discovery through licensure, global regulatory leadership, cross-functional collaboration, and experience with major regulatory authorities like FDA and EMA. Work setup: In-person at one of the specified locations with flexible work arrangements.