Associate Director, CMC Regulatory Affairs - CGT (Hybrid)

AstraZeneca; Cambridge (MA); Hybrid; USD 136,000 - 203,000; Full time

Job summary

AstraZeneca plc in the United States seeks an Associate Director, Regulatory Affairs, CMC - CGT to lead the regulatory strategy for our Cell & Gene Therapies portfolio. This hybrid role may be based in Santa Monica, CA, Gaithersburg, MD or Boston, MA, and reports to the Senior Director, CMC-CGT Regulatory Affairs.

You will partner with cross-functional teams to deliver regulatory dossiers (IND/IMPD/BLA/Master Files), provide submissions-ready CMC modules, and support manufacturing changes and

Qualifications

• Minimum 8 years experience with a Master in life sciences.
• Cell/gene therapy experience preferred.
• Knowledge of global CMC regulations and health authority expectations.

Responsibilities

• Interpret global regulations and guide cross-functional product teams.
• Deliver regulatory dossiers (CMC components of IND/IMPD/BLA/Miling Files) and health authority briefing documents.
• Support Reg CMC activities in complex programs.
• Ensure submission documents are of high quality in content, organization, and accuracy.
• Represent CMC regulatory affairs on product teams and health authority interactions.
• Provide regulatory assessments for manufacturing changes and quality compliance.
• Develop and maintain regulatory templates, best practices, and procedures.
• Deliver submission-ready CMC modules to stakeholders in compliance with AstraZeneca systems.

Skills

Cross-functional collaboration

Excellent communication

Leadership

Regulatory strategy

Attention to detail

Education

Master's degree in life sciences

PhD (preferred)

Job description

AstraZeneca plc in the United States seeks an Associate Director, Regulatory Affairs, CMC - CGT to lead the regulatory strategy for our Cell & Gene Therapies portfolio. This hybrid role may be based in Santa Monica, CA, Gaithersburg, MD or Boston, MA, and reports to the Senior Director, CMC-CGT Regulatory Affairs.

You will partner with cross-functional teams to deliver regulatory dossiers (IND/IMPD/BLA/Master Files), provide submissions-ready CMC modules, and support manufacturing changes and