In this pivotal role, you will guide the regulatory strategy for cell and gene therapies, ensuring timely approvals and competitive labeling that enhance patient outcomes. You will collaborate with senior leaders and global teams, managing strategies across critical milestones from expedited designations to post-approval activities.

About the Company

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company dedicated to developing innovative therapies for serious diseases. We foster an inclusive culture that values diverse perspectives and empowers our employees.

The Role

You will be responsible for shaping the regulatory path for complex products, engaging with health authorities, and leading cross-functional teams to ensure compliance and strategic alignment.

Responsibilities

• Contribute to and implement global regulatory strategies for cell and gene therapy products.
• Serve as the regulatory lead for specific products or programs.
• Ensure regulatory strategies facilitate efficient approval paths and competitive labeling.
• Drive strategy for Health Authority interactions and submissions.
• Lead assessments of emerging data against program goals.
• Support delivery of regulatory milestones and risk mitigation strategies.
• Prepare regulatory documents and target product labeling.
• Collaborate with global teams to advance development objectives.
• Participate in initiatives to enhance regulatory processes and tools.
• Align with country organizations on local regulatory considerations.
• Provide mentorship to junior colleagues.

Requirements

• Advanced degree in a science-related field.
• 5-8 years of experience in regulatory affairs or related areas.
• Strong understanding of global regulatory science and drug development processes.
• Proven experience leading regulatory teams and managing stakeholder relationships.
• Excellent communication and organizational skills.
• Ability to work in a fast-paced, dynamic environment.

Nice to Have

• Experience in cell or gene therapy regulatory strategy.
• Background in oncology, autoimmune diseases, or rare diseases.
• Familiarity with global regulatory approvals and major submissions.
• Experience with FDA advisory committees or EMA submissions.

What We Offer

• A collaborative work environment that values curiosity and innovation.
• Opportunities for growth and development in a supportive culture.
• A commitment to diversity and inclusion in the workplace.

Step into a role where your regulatory leadership accelerates life-changing therapies—seize this opportunity to shape strategy, deliver approvals, and grow your influence today.