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. 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.