Global CMC Regulatory Director for Cell & Gene Therapy

AstraZeneca plc; Gaithersburg (MD); On-site; USD 186,000 - 279,000; Full time

Job summary

AstraZeneca plc seeks a Director of Regulatory Affairs CMC to steer global CMC strategy for cell and gene therapies, turning pioneering science into high-quality submissions and decisive health authority interactions that accelerate patient access.

Based in Santa Monica, CA or Gaithersburg, MD, or Boston, MA, you will lead end-to-end regulatory pathways, collaborate with technical, clinical, and quality partners, and drive rapid approvals across a growing pipeline.

Qualifications

• MA/MS degree in life sciences required; advanced degree preferred (PhD, PharmD).
• Experience leading complex programs and cross-functional teams.
• Strong written and verbal communication, with ability to interact with health authorities.

Responsibilities

• Global CMC strategy: lead global regulatory strategies for cell and gene therapy programs.
• Regulatory intelligence: interpret regulations and provide input to cross-functional teams; deliver assessments.
• Dossier leadership: manage CMC components of IND/IMPD/BLA/MAA filings; health authority briefing documents.
• Lifecycle management: maintain regulatory dossiers and ensure timely updates.
• Standards and ways of working: develop templates and best practices for faster execution.
• People leadership: hire, develop, and lead high-functioning teams.
• Continuous improvement: drive data-driven approaches to shorten development cycles.

Skills

Cross-functional leadership

Communication

Leadership

Time management

Attention to detail

Organization

Education

MA/MS in life sciences

Advanced degree (PhD/PharmD)

Job description

AstraZeneca plc seeks a Director of Regulatory Affairs CMC to steer global CMC strategy for cell and gene therapies, turning pioneering science into high-quality submissions and decisive health authority interactions that accelerate patient access.

Based in Santa Monica, CA or Gaithersburg, MD, or Boston, MA, you will lead end-to-end regulatory pathways, collaborate with technical, clinical, and quality partners, and drive rapid approvals across a growing pipeline.