Director, Intl CMC Regulatory Affairs – Gene Therapy

AstraZeneca plc; Barcelona; Hybrid; EUR 180,000 - 240,000; Full time

Job summary

AstraZeneca plc seeks a Director, International CMC Regulatory Affairs – Cell and Gene Therapy to lead strategic CMC regulatory efforts for a biologics portfolio across clinical development, registration, launch and lifecycle management. You will shape international strategies, address regulatory expectations, and enable high-quality submissions while partnering with global teams and health authorities.

You will drive policy, implement agile practices, and build capability across internal and

Qualifications

• Deep knowledge of global CMC regulatory requirements for biologics and advanced therapies.
• Direct experience with cell and gene therapy development and commercialization.
• Experience with IND, IMPD, BLA, MAA submissions and post-approval activities.
• Strong stakeholder management across regulatory, development, manufacturing and QA.
• Ability to lead complex regulatory programs in a matrix environment.

Responsibilities

• Lead international CMC regulatory strategies across development, registration, launch and lifecycle.
• Interpret global CMC regulations and translate into strategic advice for product teams.
• Represent AZ with health authorities and industry groups to discuss emerging regulations.
• Identify regulatory risks and develop pragmatic mitigation strategies.
• Provide regulatory assessments for manufacturing changes and technical risk.
• Lead or coordinate CMC submissions and associated briefing materials.
• Ensure timely, compliant delivery of regulatory activities and milestones.
• Engage cross-functionally to shape policy and process in advanced therapies.

Skills

CMC regulatory leadership

Cell & gene therapy regulatory

Global filings

Regulatory strategy

Health authority interactions

Cross-functional leadership

Risk assessment & mitigation

Strategic advising

Project leadership

Scientific communication

Education

Life sciences degree

CMC regulatory experience (10+ years)

Job description

AstraZeneca plc seeks a Director, International CMC Regulatory Affairs – Cell and Gene Therapy to lead strategic CMC regulatory efforts for a biologics portfolio across clinical development, registration, launch and lifecycle management. You will shape international strategies, address regulatory expectations, and enable high-quality submissions while partnering with global teams and health authorities.

You will drive policy, implement agile practices, and build capability across internal and