Regulatory Affairs Manager (ATMP)
Core
Develop regulatory strategy and documentation for novel advanced therapy medicinal products (ATMPs) treating cancer and autoimmune diseases in EU and core international markets.
Role type
Manager, Regulatory Affairs (ATMP)
Builds
Regulatory submissions and strategies for CAR T-cell therapy and other immunotherapies
Domain
Biopharma / Cell Therapy / Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
regulatory strategy development, clinical trial application preparation, cross-functional team leadership, EU regulatory compliance, document management systems, stakeholder management
Preferred skills
experience with centrally approved products, post-approval activities, tight timeline project execution
Technologies
document management systems
Responsibilities
Lead regulatory activities for development or marketed ATMP products; prepare regulatory strategy and documentation for Clinical Trial Applications/amendments; coordinate submissions for assigned projects and territories in line with ICH and regional requirements; represent Regulatory Affairs in cross-functional teams; maintain knowledge of EU regulatory requirements and communicate changes to teams.
Seniority
Manager, hands-on IC