Director, Regulatory Affairs Strategy - Cell Therapy

AstraZeneca • Gaithersburg, MD

5d • Hybrid

About The Position

This Director role will shape the global regulatory strategy for cell therapies that redefine standards of care. The position involves guiding programs across oncology, immune-mediated, and rare diseases, translating scientific breakthroughs into timely approvals and competitive labeling. The role operates within a high-performing, cross-functional environment where regulatory insight is crucial for program decision-making. The Director will partner with senior leaders and global teams to lead strategy across key milestones, including expedited designations, Health Authority interactions, major submissions, and post-approval maintenance, ensuring the delivery of transformative therapies with pace and rigor.

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.

Nice To Haves

• Experience in cell therapy regulatory strategy or related regulatory activities.
• Experience with product development in the following therapeutic areas: oncology, autoimmune, rare diseases, neurology.
• Experience supporting a global regulatory approval or major submission activity.
• Experience with FDA advisory committee or EMA oral explanation preparation.
• Experience working on due diligence activities or in a business alliance environment.
• Experience mentoring colleagues or contributing to team development.
• Contribution to non-project business initiatives or cross-functional improvement activities.

Responsibilities

• 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.

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