Associate Director, CMC Regulatory Affairs – CGT

AstraZeneca plc; Kendall Square (MA); Hybrid; USD 136,000 - 203,000; Full time

Job summary

AstraZeneca plc is seeking an Associate Director, Regulatory Affairs, CMC for CGT. The role supports the development of CMC regulatory strategy for Cell & Gene Therapies and is hybrid, based in the US (Boston, MA or Santa Monica, CA or Gaithersburg, MD).

You will lead cross-functional teams and manage dossiers across IND/IMPD/BLA lifecycle. The position requires 8+ years with a Master's in life sciences (or 6 years with a PhD), and experience in cell/gene therapy is preferred.

Qualifications

• Minimum 8 years with a Master's degree in life sciences or 6 years with a PhD.
• Prior experience in cell/gene therapy is preferred.
• Knowledge of global CMC regulations and health authority expectations for cell therapies.
• Experience in IND, IMPD, BLA, and MAA filings is preferred.

Responsibilities

• Interpret global regulations and guidance to identify risks for cross functional product teams.
• Deliver regulatory dossiers (CMC components of IND/IMPD/BLA/Master Files) and health authority briefing documents; manage dossiers throughout the lifecycle.
• Support Reg CMC activities in complex programs.
• Provide review and ensure submission documents are of high quality in content, organization, clarity, and accuracy.
• Represent CMC regulatory affairs on product teams and in health authority interactions.
• Provide regulatory assessments for manufacturing changes and quality compliance; participate in risk assessments.
• Support development and maintenance of regulatory templates, best practices and procedures.
• Deliver submission-ready CMC modules to internal and external stakeholders in compliance with AstraZeneca systems.

Skills

Cross-functional leadership

Communication skills

Leadership

Time management

Attention to detail

Organizational skills

Education

Master's degree in life sciences

PhD

Job description

AstraZeneca plc is seeking an Associate Director, Regulatory Affairs, CMC for CGT. The role supports the development of CMC regulatory strategy for Cell & Gene Therapies and is hybrid, based in the US (Boston, MA or Santa Monica, CA or Gaithersburg, MD).

You will lead cross-functional teams and manage dossiers across IND/IMPD/BLA lifecycle. The position requires 8+ years with a Master's in life sciences (or 6 years with a PhD), and experience in cell/gene therapy is preferred.