Sr Manager, Regulatory Affairs
Core
Develop and implement regulatory product strategies for CAR T-cell therapies, leading submissions to FDA, EMA, and other authorities to support clinical trials and marketing approvals.
Role type
Senior Manager, Regulatory Affairs (US Regulatory Lead)
Builds
Regulatory strategies, IND/CTA/BLA/MAA submissions, and compliance frameworks for cell therapy products.
Domain
Biopharmaceuticals / Oncology / Cell Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy development, submission planning and review, risk assessment and mitigation, cross-functional team leadership, regulatory compliance management, stakeholder liaison with health authorities, team mentorship, policy analysis, documentation management, project timeline management
Preferred skills
Global regulatory knowledge, experience with late-stage drug development, experience leading major health authority interactions (e.g., FDA pre-NDA/BLA meetings), experience with marketed products, process improvement, cross-functional collaboration
Technologies
Regulatory submission systems, project management tools, document management platforms
Responsibilities
Develop regulatory product strategies, represent regulatory function on cross-functional teams, plan and review submissions to FDA/EMA, lead compliance activities, manage regulatory aspects of projects, serve as US Regulatory Lead, monitor regulatory intelligence, advise on regulations, coordinate with authorities, train and mentor personnel, engage in policy initiatives
Seniority
Senior Manager, hands-on leadership with strategic oversight