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CEDENT

Regulatory Affairs Lead, CRO — GCP & Submissions Expert

CEDENT, Boston, Massachusetts, us, 02298

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A regulatory affairs consulting firm is seeking a CRO Regulatory Specialist to ensure clinical trials comply with FDA, ICH, and GCP requirements. Responsibilities include developing quality management systems, conducting compliance assessments, and preparing regulatory submissions like IND/IDE. The ideal candidate has a bachelor's degree in a relevant field, 5+ years in clinical research, and experience in regulatory affairs. Strong skills in regulatory submissions and compliance assessments are essential for success in this role. #J-18808-Ljbffr