# Manager, Regulatory & Technical Writing, Process Sciences, Analytics and Technology, Cell and Gene Therapy at AstraZeneca

AstraZeneca is hiring a Manager, Regulatory & Technical Writing, Process Sciences, Analytics and Technology, Cell and Gene Therapy. It pays $137k-$205k a year and Level rates it Little AI ●○○○; you can [apply on Level](https://jobsbylevel.com/go/8e83fd74-e704-4b10-8476-1fda2489fc2f).

AI Level 1, AI centrality 31 out of 100. US – Tarzana – CA.

## Details

- Company: [AstraZeneca](https://jobsbylevel.com/companies/astrazeneca)
- AI level: AI Level 1 (score 31 out of 100)
- Location: US – Tarzana – CA
- Salary: $137k-$205k
- Posted: October 8, 2026
- Apply: https://jobsbylevel.com/go/8e83fd74-e704-4b10-8476-1fda2489fc2f

## Description

At AstraZeneca, we are united by a shared commitment to transform the lives of patients through science. Within our Cell & Gene Therapy organization, we are building next-generation capabilities that combine scientific innovation, advanced manufacturing, digital technologies, and regulatory excellence to deliver potentially life-changing medicines. As Manager, Regulatory & Technical Writing, you will play a critical leadership role in translating complex CMC and technical data into clear, compelling, and submission-ready regulatory documentation supporting AZD0120 and future Cell & Gene Therapy programs. This position offers a unique opportunity to contribute directly to BLA readiness, global regulatory submissions, health authority interactions, and the evolution of AI-enabled regulatory authoring capabilities. What You'll Do The Manager, Regulatory & Technical Writing will lead the planning, authoring, integration, review, and lifecycle management of technical and regulatory documentation supporting AZD0120 and other Cell & Gene Therapy products, with an immediate focus on BLA readiness and execution. 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, strategically aligned, and inspection ready. Key Responsibilities BLA Submission Planning & Execution Lead technical writing activities supporting the AZD0120 BLA and other global regulatory submissions. Develop submission storyboards, content strategies, authoring plans, governance models, and review frameworks. Manage critical timelines, dependencies, content readiness, decision points, and escalation pathways. Identify submission risks, content gaps, and cross-functional dependencies while driving mitigation strategies. Provide strategic updates and recommendations to functional and program leadership. Regulatory Authoring & Content Development Author, edit, and coordinate regulatory and technical documentation, including: BLA and MAA submissions CTD Module 3 content Quality Overall Summary (Module 2.3) contributions IND and CTA amendments Health authority responses and RTQs Briefing books and meeting packages Lifecycle management submissions Translate complex scientific, manufacturing, analytical, and quality information into regulator-ready content. Coordinate cross-functional reviews, comment adjudication, approvals, and publishing handoffs. CTD Module 3 Integration & Global Regulatory Support Lead development, integration, and lifecycle management of assigned CTD Module 3 content. Ensure consistency across global filings and health authority commitments. Support content updates related to process changes, analytical methods, validation activities, comparability assessments, stability data, and post-approval changes. Partner closely with Regulatory Operations and Submission Excellence to ensure publishing readiness. AZD0120 BLA & Health Authority Response Leadership Serve as a key technical-writing lead supporting BLA preparation, submission, and agency response activities. Coordinate rapid-response workstreams and health authority requests. Integrate SME contributions and ensure regulatory consistency across all responses. Maintain response repositories, precedent language, commitments, and lessons learned to enhance future readiness. Cell & Gene Therapy CMC Documentation Author and review technical content describing: Manufacturing processes Analytical methods Critical Quality Attributes (CQAs) Control strategies Validation activities Stability programs Comparability assessments Product lifecycle changes Ensure scientific accuracy, traceability, consistency, and regulatory suitability. Technical Report Development Lead authoring and editorial review of technical reports supporting process development, analytical development, characterization studies, validation, qualification, and

The description is cut here. Read the full offer: https://jobsbylevel.com/jobs/manager-regulatory-technical-writing-process-sciences-analytics-and-technology-cell-and-gene-therapy-at-astrazeneca-0d919d

Source: https://jobsbylevel.com/jobs/manager-regulatory-technical-writing-process-sciences-analytics-and-technology-cell-and-gene-therapy-at-astrazeneca-0d919d

## Cite this page

Level. https://jobsbylevel.com/jobs/manager-regulatory-technical-writing-process-sciences-analytics-and-technology-cell-and-gene-therapy-at-astrazeneca-0d919d.

Get job alerts: https://jobsbylevel.com/newsletter