Product Owner

Summary: The role of Product Owner involves leading the development and enhancement of regulatory submission products and platforms, focusing on Data Centric Submissions (DCS) and Artificial Intelligence. The individual will serve as a liaison between business stakeholders and technical teams, ensuring the delivery of top-tier data-driven submission capabilities. Key responsibilities include managing the product backlog, defining product vision, and driving the adoption of DCS principles. The position requires a strong understanding of regulatory requirements and AI technologies within a regulated environment.

Key Responsibilities:

• Own and prioritise the product backlog, defining clear user stories, acceptance criteria, and epics aligned to regulatory and business objectives
• Lead sprint planning, refinement, and review ceremonies as an active member of the Agile delivery team
• Define and communicate the product vision and roadmap to stakeholders at all levels
• Make informed trade-off decisions on scope, timelines, and quality
• Evaluate and prioritise AI-powered features, ensuring responsible and compliant use within regulated environments
• Drive the adoption and evolution of DCS principles including structured data (IDMP, ISO SPOR, FHIR), electronic Common Technical Document (eCTD), and machine-readable submission formats
• Collaborate with Regulatory Affairs to ensure submission data models meet agency requirements (EMA, FDA, MHRA, etc.)
• Work with data architects and engineers to define data standards, taxonomies, and validation rules for submission content
• Champion the transition from document-centric to data-centric regulatory processes
• Identify where AI/ML can accelerate structured data extraction, validation, and submission assembly
• Define product requirements for AI-powered capabilities including NLP-based document parsing, LLM-assisted content generation, and automated data validation
• Work with data science and ML engineering teams to shape, validate, and deploy AI models within submission workflows
• Ensure AI features meet regulatory explainability, auditability, and compliance requirements (eg, EU AI Act, FDA AI/ML guidance)
• Evaluate and integrate third-party AI tools and platforms relevant to RegTech and submission automation
• Maintain a clear ethical AI framework within the product, covering bias, transparency, and human-in-the-loop oversight
• Monitor emerging AI developments (Generative AI, RAG, agentic workflows) and assess their applicability to regulatory submissions
• Engage regularly with Regulatory Affairs, Medical Writing, Clinical Data Management, Data Science, and IT teams to gather and refine requirements
• Present product updates, AI roadmaps, and DCS strategies to senior leadership and cross-functional partners
• Act as the primary point of contact for internal customers and key external partners
• Educate and upskill stakeholders on AI capabilities and responsible use in a regulated context
• Monitor industry trends in regulatory technology (RegTech), AI in life sciences, and evolving agency guidance on data and AI submissions
• Identify opportunities to improve data quality, submission efficiency, and compliance through AI-augmented processes
• Define and track KPIs and OKRs for product performance, including AI model accuracy and adoption metrics

Key Skills:

• Proven experience as a Product Owner or Product Manager in a regulated industry (pharmaceutical, biotech, medical devices)
• Solid understanding of Data Centric Submissions, including structured regulatory data standards such as: IDMP (Identification of Medicinal Products), ISO SPOR (Substances, Products, Organisations, Referentials), eCTD (electronic Common Technical Document), FHIR (Fast Healthcare Interoperability Resources) - desirable
• Familiarity with regulatory submission requirements from agencies including EMA, FDA, and/or MHRA
• Demonstrable understanding of AI/ML concepts including NLP, Large Language Models (LLMs), machine learning pipelines, and Generative AI - with the ability to translate these into product requirements
• Experience defining requirements for AI-powered features such as intelligent classification, automated extraction, anomaly detection, or content generation
• Awareness of AI governance and compliance frameworks, including the EU AI Act, FDA AI/ML guidance, and GxP considerations for AI in regulated environments
• Strong command of Agile methodologies (Scrum/Kanban); certified preferred (CSPO, SAFe PO/PM)
• Excellent ability to translate complex regulatory data and AI requirements into actionable technical stories

Salary (Rate): undetermined

City: undetermined

Country: United Kingdom

Working Arrangements: remote

IR35 Status: inside IR35

Seniority Level: undetermined

Industry: IT