Senior International Regulatory Affairs Director

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 accel