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

Job 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 manufacturing readiness. - Ensure narratives are data-driven, scientifically sound, and aligned with approved source documentation. Document Governance & Submission Readiness - Establish document standards, templates, quality controls, and content governance practices. - Manage version control, traceability, approvals, and submission readiness activities. - Maintain content repositories, review logs, trackers, and reusable content libraries. - Perform final quality reviews to ensure publishing and submission readiness. AI-Enabled Authoring & Knowledge Management - Help shape AstraZeneca's next-generation technical writing capabilities through responsible adoption of AI-assisted authoring technologies. - Support implementation of: Generative AI solutions Retrieval-Augmented Generation (RAG) Semantic search Structured content management Knowledge management platforms Document intelligence tools - Develop governance models, content libraries, prompt frameworks, and quality controls that ensure scientific accuracy, regulatory compliance, and human accountability. Inspection & Regulatory Readiness - Support pre-license inspections, health authority inspections, and inspection-readiness programs. - Prepare documentation packages, traceability tools, briefing materials, and rapid-response deliverables. - Drive continuous improvement through lessons learned and best-practice implementation. Cross-Functional Leadership - Lead authoring sessions, review meetings, and content alignment discussions. - Coordinate external writers, consultants, editors, and data-verification resources. - Coach SMEs, scientists, and engineers on effective technical writing, source traceability, and regulatory documentation practices. - Build strong partnerships across global functions while influencing without direct authority. ## Essential Requirements ### Education - Master's degree in Life Sciences, Biotechnology, Engineering, Pharmaceutical Sciences, Regulatory Affairs, or related discipline with 8+ years of relevant experience; OR - Bachelor's degree with 10+ years of relevant industry experience. - Equivalent combinations of education and directly relevant regulatory/technical writing experience may be considered. ### Experience & Skills - Significant experience authoring and editing regulatory and technical documentation in biotechnology, pharmaceutical, biologics, cell therapy, gene therapy, or other regulated environments. - Strong working knowledge of CMC regulatory documentation and global submission requirements. - Experience supporting major marketing applications such as BLA, MAA, NDA, or equivalent submissions. - Experience developing and integrating CTD Module 3 content and Module 2.3 Quality Overall Summary contributions. - Experience responding to health authority questions and deficiency responses. - Strong scientific writing, editing, document planning, and review coordination capabilities. - Ability to interpret manufacturing, analytical, validation, comparability, stability, and quality data and translate into submission-ready narratives. - Proven success managing complex deliverables across highly matrixed organizations. - Experience with regulatory document management systems such as Veeva Vault RIM, QualityDocs, eCTD publishing environments, SharePoint, Smartsheet, or comparable platforms. - Demonstrated experience evaluating or implementing AI-assisted authoring, document review, content reuse, search, or knowledge-management technologies. - Strong understanding of responsible AI practices, information governance, confidentiality, data integrity, and regulatory compliance requirements. - Experience managing consultants, contract resources, or external writing teams. ## Desirable Qualifications - Direct experience supporting Cell or Gene Therapy BLAs and/or MAAs. - Experience supporting first marketing applications, accelerated programs, rolling submissions, or compressed review timelines. - Experience supporting pre-BLA, Type B, Type C, or Type D meetings. - Familiarity with lentiviral vector manufacturing, autologous cell therapy processes, comparability, process validation, stability, and adventitious agent safety documentation. - Experience establishing submission governance frameworks, content maps, and source-traceability programs. - Experience implementing AI-enabled content management, semantic search, RAG solutions, or structured authoring approaches within regulated environments. - Prior experience in Regulatory CMC, CMC Project Management, Regulatory Operations, or Submission Management. ## Compensation & Benefits The annual base pay for this position ranges from **$136,784.80 - $205,177.20**. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. ## Why AstraZeneca This is an opportunity to shape how transformative Cell & Gene Therapy products reach patients. You will help drive AZD0120 BLA readiness, influence next-generation technical writing capabilities, and establish scalable regulatory-authoring practices for future therapies. Working at the intersection of science, manufacturing, quality, data, and regulatory strategy, you'll collaborate with world-class experts who are united by a common purpose: delivering life-changing medicines to patients faster. **Are you ready to bring new insights and fresh thinking to the table?** ## **Date Posted** 08-Oct-2026 **Closing Date** Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.