Director, International CMC Regulatory Affairs – Cell and Gene Therapy

Posted date Sep. 30, 2026
Contract type Full time
Job ID R\-260910

Why choose AstraZeneca Spain?
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AstraZeneca Spain is a rising force in our global business. With headquarters in Madrid and our global hub in Barcelona, we’ve become an important international centre of excellence in the fight against critical disease. Boasting vibrant universities and business schools, the Barcelona ecosystem is a place where scientists can thrive. We attract a diverse workforce from across the globe, shining a beacon for innovation in a country that’s committed to clinical development.

We invite you to bring your talents to Barcelona where our respiratory medicine R\&D and Global Marketing centre offers opportunities in R\&D, IT, Commercial and HR. Or join us in Madrid and shape our growth in our BUs (Respiratory, Oncology \& CVRM ), and a range of Corporate functions. Additionally, you can find sales roles throughout the country. Together, we’re contributing to a world\-leading pipeline of therapeutics and delivering life\-changing medicines to patients.

Who do we look for?
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Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca Spain, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. Alongside technical expertise, colleagues have the resilience, energy and collaborative mindset to change lanes, work with different teams and start projects from scratch.

Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting\-edge technology. Whether you join us in Madrid or Barcelona, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day.

Success Profile
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Ready to make an impact in your career? If you're passionate, growth\-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for.

Diverse collaborators

This is a speak\-up culture that values collaboration. You’ll proactively bring your unique perspectives, experiences and skills to the table and seek the same from others. With our international team composition and the need for fast\-paced collaboration, you’ll always be building new connections with colleagues.

Cutting\-edge innovators

When you join us, you’ll be part of a team that embraces digital technology and data to transform the way we work and the work we do. Every day, you’ll help make history, empowered to ignite your creativity and build something enduring.

Resilient trailblazers

Here, the answers aren’t always available. So, you’ll need to bring a fearless, self\-starter mindset to navigate uncharted territories. You’ll harness your ceaseless energy to discover and make the necessary connections with colleagues to shape the future and achieve maximum impact.

Agile movers

Seize ownership and excel with autonomy to enjoy the constant rush of ground\-breaking discovery. Your ability to anticipate sudden shifts and adapt swiftly will prove critical as you make your mark in an environment that rewards initiative and resilience.

Responsibilities
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Job ID R\-260910 Date posted 09/30/2026
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 international business and patient needs.

• Provides authoritative CMC regulatory advice and direction in complex or novel situations.


• Influences senior stakeholders and aligns diverse functions around clear regulatory priorities and decisions.


• Leads through matrix teams rather than formal line management, creating accountability and effective collaboration.


• Balances strategic ambition, regulatory risk, technical feasibility, supply continuity and delivery timelines.


• Fosters an inclusive, learning\-focused environment that supports continuous improvement and high performance.

• Deep knowledge of global and international CMC regulatory requirements and drug and biologic development processes.


• Direct experience of cell theraoy development and commercialisation


• Strong understanding of the scientific, manufacturing and regulatory challenges associated with cell and gene therapies, including ex vivo cell therapies, in vivo gene therapies and biologics.


• Demonstrated ability to develop and execute CMC regulatory strategies across clinical and commercial stages.


• Experience leading complex submissions and health authority interactions.


• Strong judgement, risk management, problem\-solving and project leadership skills.


• Excellent written and verbal communication, with the ability to present complex issues clearly and influence decisions.


• Ability to establish trusted relationships, lead multifunctional teams, manage competing priorities and work independently in a fast\-paced environment.


• Adaptability when working with incomplete information, changing priorities or unexpected events.

Essential

• Degree or equivalent professional qualification in life sciences, pharmacy, biology, chemistry, biotechnology or a related scientific or technical discipline.


• Substantial CMC Regulatory Affairs experience; typically 10\+ years with a bachelor’s degree, 8\+ years with a master’s degree, or 6\+ years with a doctorate.


• Direct experience with cell and gene therapy and/or biologics products at clinical development and commercial stages.


• Experience with relevant global filings, such as IND, IMPD, BLA and MAA submissions, and post\-approval regulatory activities.


• Demonstrated experience of cross\-functional stakeholder management and leading complex regulatory programmes.

• Postgraduate qualification in a relevant scientific, regulatory or business discipline.


• Experience with health authority interactions, inspections, external advocacy or regulatory policy.


• Understanding of manufacturing, quality, supply chain, commercial and financial considerations relevant to advanced therapies.


• Exper

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