Director, International CMC Regulatory Affairs – Cell and Gene Therapy

About the role

AstraZeneca is looking for a Director, International CMC Regulatory Affairs for its Cell and Gene Therapy business, based in Barcelona. The role 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. It works with health authorities, product teams and cross-functional partners, and the position is split between 3 days in the office and 2 days working from home.

Key responsibilities

• Develop and implement 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 and guidance and turn them into strategic advice for product teams.
• Represent the company with international trade associations and directly with health authorities, helping shape policy and build their capabilities.
• Manage complex regulatory risks and develop mitigation strategies and solutions.
• Provide regulatory assessments for manufacturing changes, comparability, quality compliance and technical risk assessments.
• Lead or coordinate CMC submission content, including BLAs, MAAs, master files, amendments, variations, annual reports and health authority briefing materials.
• Represent the function on product teams, global regulatory strategy teams, governance forums and health authority interactions, and lead responses to health authority questions.
• Contribute to policy, advocacy, guidance and procedures, and drive agile approaches to dossier and regulatory information management.
• Lead knowledge sharing, coaching and communities of practice, and support business improvement and continuous improvement.
• Provide regulatory leadership for due diligence, in-licensing, divestment, product withdrawal and other business development activities.

Required profile

• Degree or equivalent professional qualification in life sciences, pharmacy, biology, chemistry, biotechnology or a related discipline.
• Substantial CMC Regulatory Affairs experience: typically 10+ years with a bachelor's degree, 8+ with a master's, or 6+ with a doctorate.
• Direct experience with cell and gene therapy and/or biologics products at clinical development and commercial stages.
• Experience with global filings such as IND, IMPD, BLA and MAA submissions and post-approval activities.
• Demonstrated experience leading complex regulatory programmes and managing cross-functional stakeholders.
• Desirable: postgraduate qualification, health authority interaction experience, and understanding of manufacturing, quality, supply chain, commercial and financial aspects of advanced therapies.

Required skills

• Deep knowledge of global and international CMC regulatory requirements and drug and biologic development processes.
• Experience leading complex submissions and health authority interactions.
• Strong judgement, risk management, problem-solving and project leadership.
• Excellent written and verbal communication, able to present complex issues and influence decisions.
• Ability to lead matrix teams, manage competing priorities and work independently in a fast-paced environment.