Location:
Barcelona - Spain (3 days working from the office and 2 days working from home)Introduction to the roleThe 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.
It partners across Regulatory, Cell Therapy Development, Technical Operations, Quality, Supply and country organisations to translate complex scientific, manufacturing and regulatory considerations into clear decisions and executable plans. The Director also shapes policy and process,



drives consistent and agile ways of working, and builds capability internally and externally with Health Authorities through coaching and knowledge sharing.
Key ResponsibilitiesLead the development and implementation of international CMC regulatory strategies for cell and gene therapy and biologics products across development, registration, launch and lifecycle management.
Interpret general and international CMC regulations, guidance and emerging health authority expectations, translating them into clear strategic advice for product teams. Represent AZ externally with international trade associations and directly with health authorites to discuss emerging regulations, shaping policy and build HA capability and capcity. Identify and manage complex regulatory risks, make sound judgements in novel situations, and develop pragmatic mitigation strategies and innovative solutions.
Provide strategic direction and regulatory a

📌 Director, International CMC Regulatory Affairs (Barcelona)
🏢 AstraZeneca
📍 Barcelona