Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy

Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy Introduction to role: Are you ready to set the global regulatory vision for pioneering cell and gene therapies and turn breakthrough science into real options for patients? This role leads high-impact programs across cancer, immune-mediated and rare diseases, guiding them from current stage through licensure with clear, competitive pathways to approval and labeling. You will shape strategy for complex, visible programs, bringing clarity, pace and rigor that accelerate access for patients. You will report to the Executive Director, Cell and Gene Therapy Regulatory Affairs and act as a franchise global regulatory lead for programs with multiple indications, with the opportunity to serve in a dual capacity as a regional lead based on your expertise. Working across discovery through commercialization, you will partner closely with Global Product Teams to align science, evidence and policy, while coaching a Global Regulatory Strategy Team to deliver at the highest level. Could you be the strategic voice that anticipates risk, seizes expedited opportunities and influences the dialogue with global health authorities? Accountabilities Global Regulatory Leadership: Own the end-to-end global regulatory strategy for a high-complexity cell and gene therapy program, from current stage through BLA submission, ensuring an efficient route to approval with competitive labeling aligned to product attributes and patient, market and business needs. Franchise and Regional Responsibility: Serve as global regulatory lead for complex, multi-indication programs and, where relevant, take on regional leadership to integrate region-specific strategy and execution. Health Authority Strategy and Engagement: Lead strategy for agency meetings, information requests and expedited pathway designations; drive robust preparation that secures clear outcomes and de-risks pivotal milestones. Dossier and Labeling Excellence: Direct the planning and construction of the global dossier and core prescribing information; own target product labeling strategy and negotiation readiness. Cross-Functional Product Leadership: Represent Regulatory Affairs on Global Product Teams, shaping development and commercialization plans, contributing to governance presentations and aligning regulatory objectives with clinical, CMC, safety and commercial strategies. Evidence and Decision-Making: Continuously assess emerging data against program aspirations; present risks, trade-offs and mitigations to senior leadership to enable decisive, data-driven choices. Delivery and Milestone Management: Oversee all regulatory deliverables and milestones, including probability-of-success assessments and contingency planning to protect timelines and value. Team Leadership and Talent Development: Lead a Global Regulatory Strategy Team for specific indications/programs; coach, mentor and, as applicable, line-manage team members to build capability and performance. External Influence and Partnerships: Build strong relationships with regulatory stakeholders; partner with country and regional regulatory teams to shape developing views and guidance. Innovation and Tools: Lead and promote the development of novel regulatory tools and technology, and contribute to non-project initiatives that advance how we work and the impact we deliver. Marketed Product Stewardship: Maintain accountability for product maintenance and compliance activities associated with marketed brands, ensuring continued benefit to patients and compliance with evolving requirements. Essential Skills/Experience Advanced degree in a science-related field and seven to ten years of experience and/or appropriate knowledge/experience. Demonstrated success in cell and/or gene therapy regulatory strategy. Deep 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. Experience with product development in oncology, autoimmune, rare diseases, neurology. 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. Successful leadership of at least one global regulatory approval including leading response team and labeling negotiations. Desirable Skills/Experience Experience with FDA advisory committee and/or EMA oral explanation. Experience working on due diligence activities and in a business alliance environment. Experience in leading and growing people through coaching or mentorship. Contribution to non-project business initiatives (e.g. at a portfolio or cross functional level). Pay Transparency The annual base pay for this position ranges from $218,058 - $327,087 USD Annual. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at‑will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Equal Employment Opportunity Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr