Director, CMC Regulatory Affairs - FDA Strategy & GMP

A biotechnology firm is seeking an Associate Director/Director, CMC Regulatory Affairs to lead regulatory activities for its ECO Synthesis platform. This role involves interacting with the FDA, managing regulatory submissions, and ensuring compliance with advanced manufacturing regulations. The ideal candidate will have over 8 years of experience in CMC regulatory affairs, a strong knowledge of GMP standards, and an advanced degree in a relevant field. Excellent communication and leadership skills are essential for success in this position.
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