Director, Regulatory Affairs Strategy - Cell Therapy

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. Requirements An advanced degree in a science related field and 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. Demonstrates expertise in global regulatory strategy and drug development processes, with a strong ability to lead regulatory submissions and Health Authority interactions. Possesses excellent communication and organizational skills to manage multiple projects and align cross-functional teams effectively. Highest-signal resume keywords Global Regulatory Strategy Regulatory Submissions Health Authority Interactions Stakeholder Management Drug Development Processes ATS Optimization Keywords Hard Skills Regulatory Strategy Development BLA Development Regulatory Documentation Preparation Probability-of-Success Assessments Emerging Data Assessment Soft Skills Strategic Thinking Critical Evaluation Communication Skills Organizational Skills Mentoring Industry Keywords Pharmaceutical Business Regulatory Affairs Complex CGT Products Project Management Fast-Paced Environment #J-18808-Ljbffr Jobtailor