Senior International Regulatory Affairs Director

AstraZeneca · Cambridge

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Introduction to role:

Are you ready to lead International regulatory strategy that brings breakthrough cell therapies to patients faster and with stronger, sustainable labels? In this role, you will set direction for high-complexity programs, embedding International needs early to shape evidence generation, submission strategy and labeling that accelerates access across priority markets.

You will work at the intersection of pioneering cell therapy science, International market dynamics and global product strategy. Partnering closely with Global Product and Regulatory teams, Area and country colleagues, Commercial and Medical leaders, and policy stakeholders, you will turn ambitious science into timely approvals and meaningful patient impact. How will you guide pivotal decisions, de-risk milestones and position our therapies for long-term success?

Accountabilities:

• International Regulatory Strategy and Leadership: Own the International strategy for complex cell therapy programs, ensuring regional requirements, risks and mitigations are embedded in global plans and communicated with authority across teams and governance.
• Cell Therapy Regulatory Strategy: Lead end-to-end International strategy from development through major submissions, approval, launch and life-cycle management, translating BLA, MAA and equivalent milestones into coherent International plans aligned to market needs.
• Cross-Functional Integration: Integrate clinical, CMC, safety, quality, commercial and medical considerations, including International quality regulations and manufacturing changes, so regional needs shape evidence generation and decision-making.
• Health Authority Strategy and External Influence: Orchestrate International Health Authority engagements, expedited designations and advisory preparations; brief senior leaders on scenarios and implications to drive timely, risk-aware decisions; partner with policy and industry groups to shape evolving guidance.
• Submission, Dossier and Labeling Excellence: Direct International dossier planning and construction; lead target product labeling, core prescribing information and negotiation readiness; partner with CMC stakeholders to maintain dossier readiness and deliver high-quality submissions on time.
• International Market Readiness and Alignment: Collaborate with Senior Area Regulatory Directors, country regulatory leads and International Commercial and Medical teams to anticipate market needs, resolve issues rapidly and ensure International considerations are built into clinical and regulatory plans.
• Evidence, Risk and Decision-Making: Continuously assess emerging data against approvability, patient value and competitive positioning; lead probability-of-success assessments and contingency planning that protect timelines, quality and product value.
• Matrix and People Leadership: Lead the International Regulatory Team for assigned products; provide coaching and performance feedback; create a climate of empowerment, clarity and constructive challenge across complex matrix teams.
• Innovation, Policy and Process Excellence: Champion innovative regulatory strategies, tools and ways of working; identify capability-building opportunities and policy-shaping initiatives that advance access to cell therapies in International markets.

Essential Skills/Experience:

Capabilities:

• Leading change: challenges the status quo and transforms ways of working for sustainable growth, especially in complex or novel regulatory environments.
• Strategic direction: communicates an aligned, clear vision for the future with focused priorities, and proactively responds to external trends, risks and opportunities.
• Effective thinking: integrates diverse information, interprets complex situations and synthesizes insight to see the whole picture and reach sound conclusions.
• Decision-making: makes effective and timely decisions in ambiguity, remaining composed in times of difficulty and transparent about risks and trade-offs.
• Influencing: builds collaborative networks within and outside AstraZeneca, adapting approaches to secure commitment and deliver business objectives.
• Concern for people: creates a climate of empowerment, trust and commitment, actively developing colleagues through coaching and feedback.
• Business and commercial acumen: applies AstraZeneca strategy, external business context and International market dynamics to regulatory decision-making.
• Cross-cultural effectiveness: works independently and effectively across Marketing Companies, International and Global teams, adapting communication to different cultures and stakeholder needs.
• Communication: influences and negotiates across local, global and virtual teams, business units and external parties through clear, concise and targeted communication.

Education, qualifications and experience:

• Advanced degree in a science-related field, or a bachelor's degree in a relevant scientific discipline with substantial and directly relevant regulatory experience.
• Strong international regulatory experience, with senior-level accountability in drug, biologic or cell therapy development.
• Demonstrated success in cell therapy regulatory strategy or closely related regulatory activities for high-profile, complex or novel development programs.
• Extensive knowledge of global regulatory science, International regulatory systems and global CMC regulations for CGTs and biologics, including evolving Health Authority expectations across product approval, launch and life-cycle management.
• Experience with CGT and biologic products across clinical development and commercial stages, including ex vivo and in vivo cell therapies, and familiarity with IND, IMPD, BLA, MAA and equivalent filing CMC components.
• Successful leadership of at least one major global or International regulatory approval, including response team leadership and labeling negotiations.
• Direct experience creating and implementing innovative and accelerated regulatory strategies for major submissions in International markets.
• Previous experience leading Health Authority interactions in major markets and preparing senior leaders or cross-functional teams for critical regulatory engagements.
• Broad background in the pharmaceutical business with experience across several areas of regulatory affairs, such as Global, European, International, Marketing Company or Health Authority settings.
• Experience with product development in relevant therapeutic areas such as oncology, immune-mediated or autoimmune disease, rare diseases, neurology or other cell therapy-relevant areas.
• Proven leadership and program management experience, including leading regulatory and cross-functional teams, managing stakeholders and delivering complex milestones at pace.
• Strong commercial awareness and ability to connect regulatory strategy to product value, competitive positioning, patient access and International market priorities.
• Recognised expertise in the relevant disease area or modality, with the credibility to advise internal and external networks on regulatory science questions.

Desirable Skills/Experience:

• Experience with FDA advisory committee, EMA oral explanation or equivalent major market advisory preparations.
• Experience shaping the future regulatory framework through active membership of professional societies, trade organizations, industry groups or policy forums.
• Experience working on due diligence, in-licensing, alliance management or business development activities.
• Experience leading and growing people through coaching, mentorship or line management.
• Contribution to non-project business initiatives at portfolio, cross-functional or International level.
• Experience with marketed product maintenance and compliance activities for advanced therapy or biologic products.

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 you will guide programs that turn cutting-edge cell therapy science into timely, durable access for patients, working shoulder to shoulder with diverse experts who challenge, support and learn from one another. We blend bold ambition with practical execution, harnessing advanced analytics, modern regulatory tools and deeply collaborative ways of working to deliver earlier approvals and competitive labels. Your leadership will influence pivotal milestones across priority markets, while a culture that values curiosity, kindness and ownership gives you the space to innovate, grow and make your impact felt from lab bench to bedside.

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