Product Owner, Regulatory Intelligence and Engagement

Description

The company is the company, a global biopharma business. Its R&D finds and delivers vaccines and medicines, combining immune system research with advanced technology. The stated aim is to positively affect the health of 2.5 billion people by the end of the decade.

This is a Senior Product Owner role for Regulatory Intelligence and Health Authority Engagement. You will own the digital products behind regulatory intelligence, health authority engagement and transparency work inside the Evidence Presentation & Regulatory portfolio. The role sits in R&D Digital & Technology and turns the needs of Regulatory Affairs, Clinical and wider R&D into clear user requirements. The aim is for regulatory teams to get timely intelligence, structured insight and simple tools for dealing with agencies such as the FDA, EMA, MHRA and PMDA.

You will be the technology lead for the Regulatory Intelligence workstream within a large strategic programme, set the roadmap for tools that handle HA questions, correspondence and insight, and mentor other Product Owners. The company's values are Ambitious for patients, Accountable for impact and Do the right thing.

Responsibilities

• Define the product vision and roadmap for Regulatory Intelligence and HA Engagement, showing how technology and AI improve regulatory success, HA interactions and transparency. Prioritise and sequence investment by value, in line with DevCMO strategy.
• Link this area with the Medical and Regulatory Content Lifecycle and other DevCMO portfolios so they form one connected, data-driven digital ecosystem.
• Use your knowledge of regulatory intelligence, HA engagement and transparency to find bottlenecks and gaps across the submissions, evidence and disclosure lifecycle. Work with design and engineering to create simple, compliant user journeys.
• Work with architects and engineers on technical trade-offs and solution design, and bring in new technology where it adds clear value.
• Make AI the default tool for prototyping, drafting and decision-making. Set AI-first expectations across the portfolio and ensure AI outputs are tested, validated and governed safely.
• Own delivery from start to finish. Release work in small increments to test value quickly, hold vendors to outcomes, and hold internal and external teams accountable for quality, speed and value.
• Build GxP, privacy and AI governance into the work from the start, keep core systems of record clean, and close risks and issues promptly.
• Build trusted relationships with senior Regulatory, Clinical and Medical stakeholders, stay aligned with peer Product Owners and Product Directors, and coach junior Product Owners toward a high-performing, autonomous team.

Requirements

• A bachelor's degree or equivalent experience in a scientific, technical or related field, such as life sciences, computer science or engineering.
• At least 5 years in digital product management or product ownership, with growing seniority, including backlog management and iterative delivery. You must be able to own the vision, roadmap and prioritisation of a workstream this size on your own.
• Experience in pharmaceutical R&D, clinical development or regulatory affairs, including direct work on regulatory submissions or health authority engagement.
• Desirable: hands-on use of regulatory intelligence tools (for example Cortellis, IQVIA or Freyr), HA Q&A or correspondence management, submissions tracking, or transparency and disclosure solutions.
• Desirable: experience leading technology workstreams within a larger programme, such as a digital transformation in a large enterprise.
• Desirable: familiarity with AI and ML solutions in regulated settings, and their validation and governance requirements.
• Desirable: a proven record of working in global, matrixed organisations and influencing cross-functional teams.
• Skills listed: Agile Methodology, Backlogs, Cross-Functional Teamwork, Design Thinking, DevOps, Process Diagrams, Product Strategies, Project Management, Requirements Gathering, Services Management, Software Development, User Experience (UX), User Research, User Story.

Conditions

The company works to an agile model for all roles. If flexibility matters to you, ask the hiring team what options exist.

If you need adjustments during the application process, contact the company's site, where you can also request a call. Other enquiries cannot be handled through that address; the Recruitment FAQ guide answers common questions.

The company does not accept referrals from employment businesses or agencies for these vacancies unless prior written authorisation has been obtained from its commercial and general procurement or HR department. Without that authorisation, the company is not liable for any fees.

If you are a US licensed healthcare professional, or a healthcare professional as defined by the law of the state that issued your licence, the company may need to record and report expenses it incurs on your behalf if you are invited to interview. This is required to meet US federal and state transparency rules. Details are on the CMS Open Payments website.

The company is committed to equal opportunity.

Benefits

• The company describes its culture as one that lets people thrive and focus on what matters most.