Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy

AstraZeneca • Gaithersburg, MD

4d • Hybrid

About The Position

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. This role is for a strategic voice that anticipates risk, seizes expedited opportunities and influences the dialogue with global health authorities.

Requirements

• An 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 the following therapeutic areas: 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.

Nice To Haves

• 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).

Responsibilities

• 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.
• Serve as global regulatory lead for complex, multi-indication programs and, where relevant, take on regional leadership to integrate region-specific strategy and execution.
• Lead strategy for agency meetings, information requests and expedited pathway designations; drive robust preparation that secures clear outcomes and de-risks pivotal milestones.
• Direct the planning and construction of the global dossier and core prescribing information; own target product labeling strategy and negotiation readiness.
• 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.
• Continuously assess emerging data against program aspirations; present risks, trade-offs and mitigations to senior leadership to enable decisive, data-driven choices.
• Oversee all regulatory deliverables and milestones, including probability-of-success assessments and contingency planning to protect timelines and value.
• Lead a Global Regulatory Strategy Team for specific indications/programs; coach, mentor and, as applicable, line-manage team members to build capability and performance.
• Build strong relationships with regulatory stakeholders; partner with country and regional regulatory teams to shape developing views and guidance.
• 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.
• Maintain accountability for product maintenance and compliance activities associated with marketed brands, ensuring continued benefit to patients and compliance with evolving requirements.

Benefits

• short-term incentive bonus opportunity
• equity-based long-term incentive program
• retirement contribution
• commission payment eligibility
• qualified retirement program (401(k) plan)
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director