Director, Regulatory Affairs Strategy – Cell Therapy

AstraZeneca

. Contribute to and implement the global regulatory strategy for a complex CGT product or indication through key submission milestones and product maintenance activities .

Posted 11/4/2026full-timeBarcelona • SpainLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in global regulatory strategy and drug development processes, particularly in complex CGT products. Proven ability to lead regulatory submissions and Health Authority interactions while mentoring cross-functional teams.

Highest-signal resume keywords

Global Regulatory StrategyRegulatory Submission LeadershipHealth Authority InteractionsDrug Development ProcessesCell Therapy Regulatory Experience

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentBLA Development and SubmissionRisk Assessment and MitigationTarget Product LabelingRegulatory Dossier AssemblyFDA Advisory Committee PreparationEMA Oral Explanation PreparationProbability-of-Success AssessmentsRegulatory Affairs KnowledgeProject Management

Soft Skills

Excellent Oral CommunicationStrong Organizational SkillsStrategic ThinkingMentoring and Team DevelopmentAdaptability

Certifications & Qualifications

Advanced Degree in Science

Industry Keywords

Pharmaceutical BusinessComplex CGT ProductsOncologyAutoimmune DiseasesRare DiseasesNeurologyRegulatory AffairsCross-Functional Team LeadershipStakeholder ManagementGlobal Regulatory Approval

Tech Stack

Tools & technologies

Assembly

About the role

Key responsibilities & impact

Contribute to and implement the global regulatory strategy for a complex CGT product or indication through key submission milestones and product maintenance activities
Serve as regulatory lead for a product, indication, or defined program component, potentially as Global Regulatory Lead and regional regulatory lead
Ensure regulatory strategies enable an efficient approval path with competitive labeling aligned to product, business, market, and patient needs
Drive strategy and execution for Health Authority meetings, information-request responses, expedited pathway designations, and BLA development and submission
Assess emerging data against program aspirations and communicate risks and mitigation plans to senior management
Support project-related regulatory milestones, including probability-of-success assessments and mitigation strategies
Lead preparation of regulatory strategy documents and target product labeling
Support planning and assembly of the global dossier and core prescribing information
Operate as a core member of the Global Product Team and Global Regulatory Strategy Team
Participate in initiatives to enhance regulatory processes, tools, and practices and foster knowledge sharing
Partner with country organizations and regional regulatory colleagues on local considerations and regulatory guidance
Mentor and provide matrix support to less experienced colleagues, with possible limited line management responsibilities

Requirements

What you’ll need

An advanced degree in a science related field
Typically five to eight years of experience and/or appropriate knowledge/experience
Understanding of global regulatory science and integration with program strategy
Long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs
Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs
Proven experience leading regulatory and cross-functional teams, and stakeholder management
Ability to think strategically and critically and evaluate risks to regulatory activities
Previous experience in leading Health Authority interactions in major markets
Excellent oral, written, and presentation skills
Strong organizational skills
Ability to work in a fast-paced environment in a hands-on fashion
Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities
Experience in cell therapy regulatory strategy or related regulatory activities
Experience with product development in oncology, autoimmune, rare diseases, or neurology
Experience supporting a global regulatory approval or major submission activity
Experience with FDA advisory committee or EMA oral explanation preparation
Experience working on due diligence activities or in a business alliance environment
Experience mentoring colleagues or contributing to team development
Contribution to non-project business initiatives or cross-functional improvement activities

Benefits

Comp & perks

Flexible working arrangements while balancing an expectation of being in the office
Mentoring and support for professional growth
Inclusive and diverse workplace
Opportunity to work with cutting-edge technology and data automation
Collaboration with global teams and colleagues across disease areas
Visible impact on life-changing medicines and patient outcomes