Director, International CMC Regulatory Affairs – Cell and Gene Therapy

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Location: Barcelona - Spain (3 days working from the office and 2 days working from home) Introduction to the role The Director, International CMC Regulatory Affairs – Cell and Gene Therapy provides strategic, operational and tactical CMC regulatory leadership for a portfolio of cell and gene therapies and biologics across clinical development, registration, launch and post-approval lifecycle management. The role develops and delivers international CMC strategies that anticipate evolving health authority expectations, identify risks and mitigations, and enable high-quality, timely submissions aligned with patient, market and business needs. The role represents iCMC on cross-functional product and governance teams and, where required, in interactions with health authorities.…

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