Director, International CMC Regulatory Affairs – Cell and Gene Therapy

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.

Leadership and Decision-Making

• 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.

Essential Skills and Capabilities

• 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.

Education and Experience

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 bachelors degree 8 years with a masters 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.

Desirable

• 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.

• Experience of due diligence in-licensing divestment or product withdrawal activities.

Key Relationships

Internal

• International and global regulatory functions

• Country regulatory teams and international market leadership

• Pharmaceutical Development Biopharmaceutical Development and Pharmaceutical Sciences

• Technical Operations Manufacturing and site Quality groups

• Global Supply Chain and Strategy

• Global product regulatory strategy and lifecycle teams

External

• Health authorities and regulatory agencies

• Industry associations policy forums and external scientific or regulatory experts

• External partners supporting development manufacture licensing or due diligence

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.