Director, Regulatory Affairs Strategy - Cell Therapy
Core
Shape global regulatory strategy for complex cell therapy programs spanning oncology, immune-mediated, and rare diseases to ensure timely approvals and competitive labeling.
Role type
Director, Regulatory Affairs Strategy
Builds
Global regulatory strategy documents, target product labeling, and core prescribing information for cell therapy products.
Domain
Biopharmaceuticals / Cell and Gene Therapy (CGT)
Required skills
Global regulatory strategy, cell therapy expertise, Health Authority engagement, drug/biologic development lifecycle, cross-functional team leadership, risk assessment, strategic planning
Preferred skills
Advanced degree (MSc/PhD/MD), oncology/autoimmune/rare disease experience, FDA advisory committee/EMA oral explanation preparation, due diligence experience, mentoring
Technologies
Regulatory submission systems, dossier assembly tools
Responsibilities
Lead global regulatory strategy from current stage through key submission milestones; drive Health Authority meetings and expedited pathway designations; prepare regulatory strategy documents and target product labeling; mentor team members; align regional regulatory views.
Seniority
Director, strategic leadership with hands-on execution