Director, Regulatory Affairs Strategy - Cell Therapy

Role: Lead global regulatory strategy for cell therapies across oncology, immune-mediated, and rare diseases, managing programs from pivotal data through approval and post-market. Responsibilities: develop and implement regulatory strategies, serve as regulatory lead for products/indications, drive health authority engagements, support submission planning, and ensure timely milestone delivery. Collaborate cross-functionally within global teams, contribute to process improvements, and mentor colleagues. Requirements: Bachelor's in a science field; 5+ years in regulatory affairs with a focus on cell therapy; strong understanding of global regulatory science, drug/biologic development, and experience leading health authority interactions. Preferred: MSc./PhD/MD; experience in oncology, autoimmune, or rare disease therapies; involvement in global regulatory approvals, advisory committees, or due diligence. HighValue: cell therapy, oncology/autoimmune/rare diseases, global regulatory strategy, health authority negotiations, program leadership. WorkSetup: flexible location options (MD, MA, CA); in-person presence at least three days/week, with flexibility. The role involves strategic decision-making to facilitate efficient approvals, competitive labeling, and alignment with global/regional regulatory requirements.