Regulatory Strategy Director, Cell Therapy

AstraZeneca; Kendall Square (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

AstraZeneca is seeking an Associate Regulatory Affairs Director to lead regulatory strategy for cutting-edge cell therapy programs in a global context. The role collaborates with senior regulatory experts to shape submission plans, align with global requirements, and drive timely interactions with health authorities.

The incumbent will oversee end-to-end submission planning, contribute to governance, and mentor team members while operating in a dynamic, cross-regional environment.

Qualifications

• Bachelor’s degree in science or regulatory field required.
• 5+ years regulatory experience in biopharma or health authority.
• Strong knowledge of drug development and regulatory processes.
• Proven leadership and project management skills.
• Experience leading cross-functional teams in regulatory programs.

Responsibilities

• Define stage-appropriate regulatory strategy across regions for cell therapies.
• Plan, prepare, review, and submit regulatory dossiers (IND/CTA/BLA/IVDR).
• Identify submission risks and opportunities to accelerate development.
• Engage with Health Authorities to obtain feedback and guidance.
• Coach and mentor regulatory team members and share knowledge.

Skills

Regulatory strategy

Project management

Leadership

Cross-functional collaboration

Regulatory submissions

Education

Bachelor's degree in science or regulatory field

Master's/PhD (preferred)

Tools

MS Project

Document management systems

Job description

AstraZeneca is seeking an Associate Regulatory Affairs Director to lead regulatory strategy for cutting-edge cell therapy programs in a global context. The role collaborates with senior regulatory experts to shape submission plans, align with global requirements, and drive timely interactions with health authorities.

The incumbent will oversee end-to-end submission planning, contribute to governance, and mentor team members while operating in a dynamic, cross-regional environment.