We have a current opportunity for a Associate Director, Regulatory Affairs CMC -Cell/Gene therapy on a permanent basis. The position will be based in Cambridge.
Responsible and accountable for regulatory CMC development strategy for cell and gene therapy programs.
Demonstrates leadership and comprehensive understanding of global RA CMC regulations and guidelines
Successfully communicates and negotiates with international Health Authorities
8+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead
Experience with pharmaceutical development of cell and gene therapies
Proven ability to provide strategic regulatory guidance to drug development
Excellent written and oral communication skills
For further information about this position please apply.