Therapist

• Contribute to and implement the global regulatory strategy for a complex CGT product or indication from current stage through key submission milestones; support product maintenance activities as needed.
• Serve as regulatory lead for a product, indication, or defined program component; may serve in a dual role as Global Regulatory Lead and regional regulatory lead.
• Ensure regulatory strategies enable an efficient path to approval with competitive labeling aligned to product characteristics and business, market, and patient needs; contribute to governance presentations.
• Drive strategy and execution for Health Authority meetings, responses to information requests, expedited pathway designations, and BLA development and submission.
• Maintain strong disease area knowledge; lead objective assessments of emerging data versus program aspirations; communicate risks and mitigation plans to senior management.
• Support delivery of all 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 with the respective teams.
• Operate as a core member of the Global Product Team and Global Regulatory Strategy Team, demonstrating strong strategic, communication, and collaboration skills to advance development objectives.
• Participate in non-project initiatives to enhance regulatory processes, tools, and practices; foster knowledge sharing across locations and therapy areas.
• Partner with country organizations and regional regulatory colleagues to align on evolving views, local considerations, and regulatory guidance.
• Provide mentoring and matrix support to less experienced colleagues; may have limited line management responsibilities.

Director of Regulatory Affairs Strategy shaping global cell therapy approvals at AstraZeneca.

Director, Regulatory Affairs Strategy – Cell Therapy

Director of Regulatory Affairs Strategy steering regulatory strategy for cell therapies at AstraZeneca. Leading multifaceted cross-functional initiatives to ensure timely approvals and effective labeling.

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Director, Regulatory Affairs Strategy – Cell Therapy