At a Glance
- Tasks: Lead the development of innovative regulatory submission products and improve data-centric processes.
- Company: Join a leading pharmaceutical company focused on regulatory technology.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Dynamic role with a focus on continuous improvement and industry trends.
- Why this job: Make a significant impact in the evolving field of regulatory submissions.
- Qualifications: 15+ years in product ownership within regulated industries and strong Agile experience.
The predicted salary is between 80000 - 100000 £ per year.
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.
Product Owner-Data Centric Submissions in Watford employer: Excelra
Join a forward-thinking company in Stevenage that prioritises innovation and excellence in regulatory submissions. As a Product Owner, you will thrive in a collaborative work culture that values continuous improvement and professional growth, offering opportunities to lead impactful projects in the pharmaceutical sector. With a commitment to employee development and a focus on data-centric solutions, this role provides a unique chance to shape the future of regulatory processes while enjoying a supportive and dynamic environment.
StudySmarter Expert Advice🤫
We think this is how you could land Product Owner-Data Centric Submissions in Watford
✨Join Product Management Meetups
Get involved in local product management meetups or workshops. These events are perfect for meeting industry folks, sharing ideas, and staying updated on trends. Plus, you never know who might be hiring—it's a fantastic way to make connections that could lead to a job at places like Excelra!
✨Show Off Your Product Sense
Create case studies or mini-projects showcasing your product management skills, and share them on platforms like Medium or LinkedIn. This not only puts your skills on display but also boosts your visibility in the product community. Imagine how impressed the hiring team at Excelra would be by your initiative!
✨Utilise Online Communities
Dive into online product management communities like Product Coalition or Mind the Product. Engage in discussions, ask questions, and share your insights. These platforms are goldmines for networking and finding hidden job opportunities—many companies often scout talent from within these circles.
✨Leverage Your University Network
If you’ve recently graduated or are still in uni, tap into your alumni network for connections in product management. Many universities have their own job boards and affinity resources to help graduates land roles. Don't forget to keep an eye out for job openings at Excelra through your school's career services!
We think you need these skills to ace Product Owner-Data Centric Submissions in Watford
Some tips for your application 🫡
Show Off Your Product Passion:When applying for a product management role like Product Owner-Data Centric Submissions, let your passion for developing products shine through in your cover letter. Share specific examples of products you've managed, how you solved user needs, and any successful outcomes you've achieved. This is your chance to showcase your understanding of the product lifecycle!
Highlight Your Cross-Functional Skills:Product management isn't just about understanding the product; it’s about collaborating with different teams! Make sure to emphasise your experience working with developers, designers, and marketers. Use your CV to showcase your ability to bridge gaps between these areas, and include relevant experiences that demonstrate your communication and leadership skills!
Include Your Metrics and Achievements:In a full-time product management application, data speaks volumes! Quantify your achievements wherever possible. Did you increase user retention by a certain percentage? Launch a product ahead of schedule? Include these metrics in your CV to paint a picture of your impact and effectiveness in previous roles.
Tailor Your CV to the Role:Make sure your CV is tailored for the Product Owner-Data Centric Submissions position at Excelra. Use keywords from the job description and ensure your relevant experiences are front and centre. Highlight any certifications or relevant training you’ve completed that will make you stand out as a strong candidate for the role. And remember, we’re excited to see your application on our website!
How to prepare for a job interview at Excelra
✨Understand the Product Life Cycle
As a product management candidate, we need to get our head around the complete product life cycle. Be prepared to discuss real-world examples of how you’ve managed product development from ideation to launch. Bring specific insights on tools like JIRA or Trello that can help streamline these processes.
✨Showcase Your Cross-Functional Skills
Product management is all about collaboration. We should be ready to highlight how we’ve worked across teams—think marketing, engineering, and design. Prepare to discuss scenarios where you had to mediate differing opinions and how you got everyone on board with a shared vision.
✨Prepare for Case Studies
In a full-time role, we can expect to encounter case study questions during our interviews. Practise solving hypothetical product problems on the spot, such as prioritising features for a new app or improving user engagement metrics. This will show our analytical thinking and decision-making skills.
✨Know Your Metrics
Let’s face it, numbers are our best friends in product management. We should prepare to discuss key performance indicators (KPIs) and how we've used analytics to inform product decisions. Dive into examples where data has driven our strategy for improvements or justified product changes.
