Regulatory & Technical Writing Lead - Cell & Gene Therapy

AstraZeneca; Los Angeles (CA); On-site; USD 137,000 - 205,000; Full time

Benefits offered by this job

Incentive bonuses

Retirement plan

Health insurance

Job summary

AstraZeneca seeks a Manager of Regulatory & Technical Writing to lead the planning, authoring, and lifecycle management of boundary-pushing CMC and regulatory content for AZD0120 and future gene therapies.

You’ll collaborate across Regulatory, Process Development, Analytical Development, MSAT, and Manufacturing to deliver submission-ready materials, support health authorities, and help shape AI-enabled regulatory authoring capabilities.

Qualifications

• Significant experience authoring and editing regulatory and technical documentation in biotechnology or pharma.
• Strong working knowledge of CMC regulatory documentation and global submission requirements.
• Experience supporting major regulatory submissions such as BLA, MAA, NDA, or equivalents.

Responsibilities

• Lead planning, authoring, integration, review, and lifecycle management of regulatory documentation for CTD Module 3 and BLA submissions.
• Coordinate cross-functional reviews and ensure regulator-ready narratives are accurate and compliant.
• Manage document governance, version control, and submission readiness.

Skills

Regulatory writing leadership

CMC knowledge

Life sciences writing

Cross-functional collaboration

AI in regulatory writing

Education

Master's degree in Life Sciences or Regulatory Affairs

Bachelor's degree + 10+ years experience

Tools

Veeva Vault RIM

eCTD publishing

SharePoint

QualityDocs

Job description

AstraZeneca seeks a Manager of Regulatory & Technical Writing to lead the planning, authoring, and lifecycle management of boundary-pushing CMC and regulatory content for AZD0120 and future gene therapies.

You’ll collaborate across Regulatory, Process Development, Analytical Development, MSAT, and Manufacturing to deliver submission-ready materials, support health authorities, and help shape AI-enabled regulatory authoring capabilities.