Regulatory Writing Lead — Cell & Gene Therapy (BLA)

AstraZeneca; California (MD); On-site; USD 137,000 - 205,000; Full time

Job summary

AstraZeneca seeks a Manager, Regulatory & Technical Writing to lead planning, authoring, integration, review, and lifecycle management of technical and regulatory documentation for AZD0120 and other Cell & Gene Therapy products, with a focus on BLA readiness.

You will partner across Regulatory, Process Development, Analytical Development, MSAT, Manufacturing, Quality, Supply Chain, Regulatory Operations, and Submission Excellence to ensure regulatory submissions are scientifically accurate,

Qualifications

• Master's degree or equivalent with 8+ years of regulatory/technical writing experience.
• Bachelor's degree with 10+ years of relevant industry experience accepted.
• Experience authoring and editing regulatory/technical documents in biotech or pharma.

Responsibilities

• Lead authoring and editorial activities for AZD0120 BLA and global regulatory submissions.
• Develop submission storyboards, content strategies, and review frameworks.
• Manage timelines, content readiness, dependencies, and escalation pathways.
• Coordinate cross-functional reviews, adjudication of comments, and publishing handoffs.
• Lead development and integration of CTD Module 3 content and regulatory responses.
• Support inspection readiness and regulatory submissions across programs.

Skills

Regulatory writing

Technical writing

Cross-functional collaboration

Leadership

Project planning

Education

Master's degree in Life Sciences, Biotechnology, Engineering, Pharmaceutical Sciences, Regulatory Affairs, or related discipline

Bachelor's degree with 10+ years of relevant industry experience

Tools

Veeva Vault RIM

QualityDocs

eCTD publishing environments

SharePoint

Smartsheet

Job description

AstraZeneca seeks a Manager, Regulatory & Technical Writing to lead planning, authoring, integration, review, and lifecycle management of technical and regulatory documentation for AZD0120 and other Cell & Gene Therapy products, with a focus on BLA readiness.

You will partner across Regulatory, Process Development, Analytical Development, MSAT, Manufacturing, Quality, Supply Chain, Regulatory Operations, and Submission Excellence to ensure regulatory submissions are scientifically accurate,