Director, Regulatory Affairs Strategy - Cell Therapy
Core
Shape global regulatory strategy for complex cell and gene therapy (CGT) programs in oncology, immune-mediated, and rare diseases to ensure timely approvals and competitive labeling.
Role type
Director, Regulatory Affairs Strategy
Builds
Global regulatory dossiers, target product profiles, and approval pathways for transformative cell therapies.
Domain
Biopharmaceuticals / Cell & Gene Therapy
Required skills
Global regulatory strategy, drug/biologic development lifecycle, Health Authority engagement, risk assessment, cross-functional team leadership, strategic planning, document preparation (BLA/dossier), stakeholder management.
Preferred skills
Cell therapy regulatory experience, oncology/autoimmune/rare disease therapeutic areas, FDA advisory committee/EMA oral hearing preparation, due diligence/business alliance experience, mentoring.
Technologies
Regulatory submission systems, clinical data management tools, collaboration platforms.
Responsibilities
Lead global regulatory strategy from current stage through key submission milestones; drive Health Authority interactions and expedited pathway designations; prepare regulatory strategy documents and target product labeling; assess emerging data against program aspirations; mentor team members.
Seniority
Director, strategic leadership with hands-on execution