Director, International CMC Regulatory Affairs – Cell and Gene Therapy

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About the role

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. 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 Responsibilities   • Lead 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 global 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 assessments for manufacturing changes, comparability, quality compliance and technical risk assessments.   • Lead or coordinate high-quality CMC submission content, including relevant components of BLAs, MAAs, master files, amendments, variations, annual reports and health authority briefing materials.   • Ensure assigned regulatory activities are delivered to agreed quality, timelines, compliance standards and business requirements.   • Represent iCMC on technical  and regulatory product teams, Global Regulatory Strategy Teams, technical and supply teams, governance forums and health authority interactions.   • Lead or support responses to health authority questions and preparation for meetings, ensuring clear scientific and regulatory positions.   • Build effective networks across Regulatory, Pharmaceutical Development, Technical Operations, Manufacturing, Quality, Supply Chain and international market organisations.   • Contribute to internal and external policy shaping, advocacy, guidance, procedures and regulatory strategy for cell and gene therapies and biologics.   • Drive consistent, agile and innovative approaches to CMC dossier management, regulatory information management and submission delivery.   • Lead knowledge sharing, coaching and communities of practice across iCMC and wider business functions.   • Support business improvement initiatives, continuous improvement and simplification, promoting consistent ways of working across International CMC Regulatory Affairs.   • Provide regulatory leadership for due diligence, in-licensing, divestment, product withdrawal and other business development activities as required.   • Lead cross-functional teams in a matrix environment and adapt priorities to meet changing int

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