Manager, Regulatory Affairs
Core
Manage the planning, compilation, QC, and submission of Investigational Drug Applications (INDs) and Biologics License Applications (BLAs) for tumor infiltrating lymphocyte (TIL) therapy and gene-edited cell therapy products.
Role type
Manager, Regulatory Affairs (Drug/Biologic Development)
Builds
Regulatory submissions (INDs, BLAs, amendments) for cell therapy products
Domain
Biotechnology / Cell Therapy / Oncology
Required skills
Regulatory submission management (IND/BLA), eCTD format expertise, international regulatory knowledge (ICH), project planning, stakeholder negotiation, document quality control
Preferred skills
Advanced degree (Master's/PhD), experience with marketed products
Technologies
Microsoft Office Suite, Adobe Acrobat Pro
Responsibilities
Manage planning and submission of INDs and BLAs; Prepare routine amendments; Coordinate with submission authors and reviewers; Maintain submission logs and correspondence with FDA; Develop submission trackers and Gantt charts; Create submission templates
Seniority
Manager, hands-on IC