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

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.

The Manager, Regulatory & Technical Writing will lead the planning, authoring, integration, review, and lifecycle management of technical and regulatory documentation supporting AZD
0120 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.

• Lead technical writing activities supporting the AZD
  0120 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.

• 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.

• 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.

• Serve as a key technical‑writing lead supporting BLA preparation, submission, and agency response activities.
• Coordinate rapid‑response work streams 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.

• 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.

• Lead authoring and editorial review of technical reports supporting process development, analytical development, characterization studies, validation, qualification, and manufacturing readiness.
• Ensure narratives are data‑driven, scientifically sound, and aligned with approved source documentation.

• Establish document standards, templates, quality controls, and content governance…