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Opportunities in Regulatory Affairs

Associate Director/Director Regulatory CMC- Cell Therapy

The CMC Regulatory Senior Director, Cell Therapy is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support Cell Therapy products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); &/or post-approval submissions. In this role, the GRS-CMC Senior Director, Cell Therapy will serve as the primary interface between Global Regulatory Sciences and Biometrics (GRSB) & Cell Therapy Development Operations (CTDO). The GRS-CMC Senior Director will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management. Submit resume to or call for more information 217-457-2222.