Associate Director, Regulatory Affairs CMC

Role: Lead Regulatory CMC strategy for CRISPR's Zugo-cel CAR-T programs, collaborating closely with development and external partners to advance gene-based therapies. Responsibilities: develop and execute regulatory strategies, prepare high-quality submissions (INDs, CTAs), liaise with health authorities, assess technical changes, and ensure compliance with global CMC regulations for biologics and gene therapies. Requirements: Bachelor's degree in biochemistry, chemistry, biology, or related fields; 12+ years (or 10+ with an advanced degree) in regulatory CMC for biologics, vaccines, or cell/gene therapies; proven success in INDs and health authority interactions; strong knowledge of FDA, EMA, ICH guidelines, and eCTD submissions. Preferred: PhD in relevant fields; experience with late-phase dossiers and global regulatory requirements. HighValue: biologics/cell/gene therapies, gene editing, IND/CTA submissions, global CMC regulation, interaction with FDA/EMA, strategic regulatory leadership. WorkSetup: hybrid with onsite presence in Boston; team-oriented environment.