Senior Regulatory Affairs Director - Oncology Cell & Gene Therapy
Core
Lead global regulatory strategy for high-complexity Oncology Cell & Gene Therapy (CGT) products from current stage through BLA submission, serving as Franchise GRL and regional lead.
Role type
Senior Regulatory Affairs Director (Oncology CGT)
Builds
Global regulatory strategies, BLA submissions, and competitive labeling for multiple myeloma treatments.
Domain
Oncology, Cell & Gene Therapy, Biologics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory strategy, BLA development, Health Authority interactions, cross-functional team leadership, risk assessment, strategic planning, stakeholder management, scientific knowledge of CGT and multiple myeloma.
Preferred skills
FDA advisory committee experience, EMA oral explanation experience, autoimmune product development, business alliance/due diligence experience, people coaching/mentorship.
Technologies
Regulatory tools and technology
Responsibilities
Lead global regulatory strategy team (GRST), prepare regulatory strategy documents and target product labeling, manage project milestones and probability of success, represent Regulatory Affairs on Global Product Teams, engage with external regulatory stakeholders, ensure product maintenance and compliance.
Seniority
Senior, hands-on IC with line management responsibilities