Product Owner – Data Centric Submissions
Location: Stevenage- UK
Required Experience - 15+ Years
About the Role
We are seeking an experienced Product Owner with deep expertise in Data Centric Submissions (DCS) to lead the development and continuous improvement of our regulatory submission products and platforms. You will act as the bridge between business stakeholders, regulatory affairs teams, and technical delivery squads, ensuring our data-driven submission capabilities are best-in-class.
Key Responsibilities:
Product Ownership:
• 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
Data Centric Submissions:
• 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
Stakeholder Management:
• Engage regularly with Regulatory Affairs, Medical Writing, Clinical Data Management, and IT teams to gather and refine requirements
• Present product updates and roadmaps to senior leadership and cross-functional partners
• Act as the primary point of contact for internal customers and key external partners
Continuous Improvement:
• Monitor industry trends in regulatory technology (RegTech) and evolving agency guidance on data submissions
• Identify opportunities to improve data quality, submission efficiency, and compliance
• Define and track KPIs and OKRs for product performance
Essential Skills & Experience:
• 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
• Strong command of Agile methodologies (Scrum/Kanban); certified preferred (CSPO, SAFe PO/PM)
• Excellent ability to translate complex regulatory data requirements into actionable technical stories
• Experience working with data modelling, metadata standards, or clinical/regulatory data management platforms
Desirable Skills:
• Exposure to xEVMPD, XSLT, RDF/OWL ontologies, or DITA in a submissions context
• Familiarity with RIMS (Regulatory Information Management Systems) such as Veeva Vault, LORENZ, or similar
• Understanding of clinical data standards (CDISC, SDTM, ADaM)
• Background in regulatory affairs, medical writing, or data governance