Global Regulatory Strategy Director — Cell Therapy

AstraZeneca plc; Barcelona; Hybrid; EUR 180,000 - 260,000; Full time

Benefits offered by this job

Three days in office per week

Flexible work arrangements

Job summary

AstraZeneca plc is seeking a Global Regulatory Leader for cell therapy programs, responsible for end-to-end strategy from discovery through licensure. You will guide multi-indication programs, collaborate with Global Product Teams, and lead a Regulatory Strategy Team to deliver robust, timely submissions across markets.

You will shape agency engagement, optimize labeling, and ensure compliance for marketed products while driving cross-functional governance and risk management.

Qualifications

• A bachelor's degree in a science related field.
• 7+ years of experience in the regulatory space.
• Demonstrated success in cell therapy regulatory strategy.
• Deep understanding of global regulatory science and integration with program strategy.
• Long standing experience in drug/biologic development processes for high profile programs.
• Experience with regulatory affairs in oncology, autoimmune, rare diseases, neurology.

Responsibilities

• Own the end-to-end global regulatory strategy for a high-complexity cell therapy program, from current stage through BLA submission.
• Serve as global regulatory lead for complex, multi-indication programs and regional leadership where relevant.
• Lead strategy for agency meetings and expedited pathways; prepare for outcomes and de-risk milestones.
• Direct global dossier planning and core labeling strategy; negotiate labeling readiness.
• Represent Regulatory Affairs on Global Product Teams and align regulatory goals with clinical, CMC, safety and commercial plans.
• Mentor and lead a Global Regulatory Strategy Team and partner with country/regional teams.

Skills

Regulatory leadership

Cell therapy

Global strategy

Stakeholder mgmt

Cross-functional

Health authority

Education

Bachelor's degree in science

Job description

AstraZeneca plc is seeking a Global Regulatory Leader for cell therapy programs, responsible for end-to-end strategy from discovery through licensure. You will guide multi-indication programs, collaborate with Global Product Teams, and lead a Regulatory Strategy Team to deliver robust, timely submissions across markets.

You will shape agency engagement, optimize labeling, and ensure compliance for marketed products while driving cross-functional governance and risk management.