Regulatory Affairs CMC Associate II
Core
Coordinate CMC submissions for clinical and commercial applications, managing planning, compilation, QC, and eCTD dossier preparation for tumor infiltrating lymphocyte (TIL) therapy products.
Role type
Regulatory Affairs CMC Associate II
Builds
Clinical trial applications (IND, CTA), commercial submissions (NDA/BLA), and associated amendments for cell therapy products.
Domain
Biotechnology / Cell Therapy / Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC dossier management, eCTD specifications, regulatory submission planning, change management, vendor/CRO coordination, log maintenance, scientific writing, data analysis, organizational planning
Preferred skills
Advanced degree (PharmD, PhD, Master's), experience with global health authorities, knowledge of ICH guidelines, familiarity with post-approval change requirements
Technologies
Microsoft Office Suite, Adobe Acrobat Pro
Responsibilities
Prepare and adapt submission documents for global clinical and commercial submissions; independently plan and prepare routine clinical trial amendments and commercial submissions; manage submission trackers for multiple products; maintain logs of submissions and correspondence with regulatory agencies; facilitate communication with vendors/CROs for source document planning; support regulatory strategy implementation for projects from IND through commercialization; create presentations for internal and external audiences.
Seniority
Mid-level, hands-on IC