Global Regulatory Strategy Director, Cell Therapy

AstraZeneca; Gaithersburg (MD); On-site; USD 218,000 - 327,000; Full time

Job summary

AstraZeneca is seeking a senior Regulatory Leader to own the global strategy for a complex cell therapy program, spanning discovery to licensure with clear pathways to approvals. You will guide evidence planning, labeling strategy and regulatory negotiations, ensuring alignment with product teams and business objectives.

The role requires leading a Global Regulatory Strategy Team, coordinating with discovery, CMC and safety groups, and engaging major health authorities.

Qualifications

• Bachelor's degree in a science related field required.
• 7+ years of experience in regulatory space.
• Demonstrated success in cell therapy regulatory strategy.
• Deep understanding of global regulatory science and integration with program strategy.
• Experience with product development in oncology, autoimmune, rare diseases, neurology.

Responsibilities

• Own the end-to-end global regulatory strategy for a multi-indication cell therapy program.
• Lead strategy for health authority meetings and expedited pathways; prepare for pivotal milestones.
• Direct the planning and construction of global dossiers and labeling strategies.
• Represent Regulatory Affairs on Global Product Teams and align regulatory with clinical and commercial plans.
• Coach and develop a Global Regulatory Strategy Team and drive cross-functional collaboration.
• Manage regulatory deliverables, milestones and risk mitigation for timely approvals.

Skills

Regulatory strategy

Global leadership

Cell therapy

Cross-functional leadership

Education

Bachelor's degree in science

Job description

AstraZeneca is seeking a senior Regulatory Leader to own the global strategy for a complex cell therapy program, spanning discovery to licensure with clear pathways to approvals. You will guide evidence planning, labeling strategy and regulatory negotiations, ensuring alignment with product teams and business objectives.

The role requires leading a Global Regulatory Strategy Team, coordinating with discovery, CMC and safety groups, and engaging major health authorities.