Executive Director, Regulatory Affairs Strategy - Cell and Gene Therapy at AstraZeneca

Barcelona, Catalonia, Spain -

Full Time

Start Date

Immediate

Expiry Date

23 Sep, 26

Salary

0.0

Posted On

25 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Cell and Gene Therapy, Health Authority Engagement, BLA Submission, Lifecycle Management, Cross-functional Leadership, Risk Management, Target Product Labeling, People Management, Strategic Planning, Dossier Construction, Regulatory Science

Industry

Pharmaceutical Manufacturing

Description

Job Title: Executive Director, Regulatory Affairs Strategy - Cell and Gene Therapy Available locations: Barcelona, Spain Amsterdam, Netherlands Introduction to role: Are you ready to set the global regulatory direction for first-in-class cell and gene therapies and turn science into approved medicines? Do you see yourself steering complex programs to competitive labels and rapid, global patient access? This role leads the strategy for our most visible and complex cell and gene therapy programs, translating breakthrough science into timely approvals and meaningful labels that unlock lifecycle value. You will work across discovery through commercialization, bringing clarity and pace to decision-making and ensuring our therapies reach patients with unmet needs. You will directly shape how we engage with health authorities, define target product labeling, and accelerate submissions across multiple indications and modalities. As a senior leader, you will build capability, coach regulatory talent, and influence policy and guidance to sustain a competitive edge for our pipeline and portfolio. Accountabilities: Global Regulatory Strategy Leadership: Own the end-to-end global regulatory strategy for a cell and gene therapy product or franchise of exceptional complexity and strategic importance, from current stage through BLA submission, approval, and lifecycle management; may serve in a dual role as Franchise GRL and regional Regulatory Affairs Director. GPT Representation and Strategic Influence: Represent Regulatory Affairs on Global Product Teams, provide strategic regulatory advice, and be accountable for all regulatory activities that shape development plans, risk management, and commercialization outcomes. Health Authority Engagement: Lead strategy for major health authority interactions, responses to critical information requests, expedited pathway designations, BLA development and submission, major post-submission interactions, and complex labeling negotiations to secure competitive labels and timely approvals. External Insight and Policy Shaping: Maintain a deep and current working knowledge of relevant disease areas, evolving scientific evidence, regulatory policy, and the external environment; establish senior external relationships to influence perspectives and maintain competitive advantage. GRST Leadership and Talent Development: Lead one or more Global Regulatory Strategy Teams focused on indications, programs, or franchise priorities; provide leadership, coaching, and performance feedback; line-manage 3–7 regulatory team members; contribute to succession planning, capability building, and development of senior regulatory talent. Data-Driven Governance and Risk Management: Deliver objective executive-level assessments of emerging data against program and portfolio aspirations; update senior management on risks, mitigation activities, probability of success, and strategic options. Milestone Delivery and Dossier Excellence: Be accountable for delivery of all project-related regulatory milestones, including probability of regulatory success assessments, mitigation planning, approval strategy, lifecycle planning; lead preparation of regulatory strategy documents and target product labeling; ensure strong strategic planning and construction of the global dossier and core prescribing information; oversee maintenance and compliance for marketed brands where applicable. Innovation and Ways of Working: Lead, participate in, and promote major non-project functional or cross-functional initiatives; drive the development and implementation of novel regulatory tools, technologies, and modern ways of working that improve quality and speed. Cross-Functional and Regional Partnership: Partner with marketing companies, regional regulatory affairs teams, and senior cross-functional stakeholders to influence developing views, guidance, and regulatory policy interpretation; coordinate across therapeutic areas and regulatory teams to deliver our cell therapies to patients. Essential Skills/Experience: An advanced degree in a science-related field and at least ten or more years of experience and/or appropriate knowledge/experience. Demonstrated extensive success in cell and/or gene therapy regulatory strategy. Deep understanding of global regulatory science and integration with program, franchise, and portfolio strategy. Long-standing experience of overall drug/biologic development processes and strategies for high profile, highly complex, novel, or first-in-class development programs. Experience with product development in the following therapeutic areas: oncology, autoimmune, rare diseases, neurology. Broad background of experience working in the pharmaceutical business and prior experience in several areas within regulatory affairs. Proven experience leading regulatory and cross-functional teams, influencing senior stakeholders, and operating effectively in complex matrix environments. Ability to think strategically and critically at enterprise level and evaluate risks to regulatory and business activities. Previous significant experience in leading Health Authority interaction 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 working on due diligence activities and in a business alliance environment. Experience in leading and growing people through line management, coaching, or mentorship. Contribution to non-project business initiatives at a portfolio, franchise, or enterprise level. Experience contributing to external policy, regulatory science, or industry advocacy initiatives. Desirable Skills/Experience: Experience with product development in oncology, autoimmune, rare diseases, and neurology across multiple indications and modalities. Experience working on due diligence activities and in a business alliance environment. Experience contributing to external policy, regulatory science, or industry advocacy initiatives. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. Why AstraZeneca: Here, transformative science meets decisive execution. You will help convert cutting-edge cell and gene therapy innovation into globally approved medicines for patients with unmet needs, working in a connected, inclusive environment that values kindness alongside ambition. We bring diverse experts together to spark bold ideas, apply modern regulatory approaches, and harness data and technology to shorten development cycles. With a rich pipeline and empowered teams, your leadership will shape labels, accelerate access, and create lasting impact for patients worldwide. Call to Action: Step into a role where your regulatory leadership defines the path from discovery to approval—take the lead and shape the future of cell and gene therapy today! Date Posted 25-Jun-2026 Closing Date 14-Jul-2026 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

Lead the global regulatory strategy for complex cell and gene therapy programs from development through BLA submission and approval. Manage regulatory teams and engage with health authorities to secure competitive labels and accelerate patient access.