Product Owner, Regulatory Intelligence and Engagement

GSK; Irvine; On-site; GBP 85,000 - 110,000; Full time

Job summary

GSK is seeking a Senior Product Owner for Regulatory Intelligence & Health Authority Engagement to lead digital products supporting regulatory intelligence, HA engagement and transparency within the Evidence Presentation & Regulatory portfolio. You will translate Regulatory Affairs needs into user requirements, drive roadmaps, mentor others and ensure governance across AI-enabled capabilities.

The role sits in the R&D Digital & Technology organization and requires collaboration with Regulatory,

Qualifications

• Bachelor’s degree or equivalent experience in a scientific, technical or related discipline (e.g. life sciences, computer science, engineering).
• ~5+ years in digital product management or product ownership across progressively senior roles, including backlog management and iterative delivery.
• Experience in pharmaceutical R&D, clinical development or regulatory affairs, with direct exposure to regulatory submissions or health authority engagement.

Responsibilities

• Set the product vision and roadmap for Regulatory Intelligence & Health Authority Engagement, articulating how technology and AI improve regulatory success, HA interactions and transparency.
• Connect the portfolio — connecting Regulatory Intelligence & Engagement with the Medical and Regulatory Content Lifecycle and other DevCMO portfolios to form a unified, data-centric digital ecosystem.
• Bring domain expertise in regulatory intelligence, HA engagement and transparency processes — spotting bottlenecks and opportunities across the submissions, evidence and disclosure lifecycle, and co-designing simple, compliant user journeys with design and engineering.
• Shape sound technical solutions with architects and engineers — shaping technical trade-offs, designing sound solutions and bringing emerging technology in where it creates value.
• Champion an AI-first approach — using AI as a default tool to prototype, draft and decide, setting AI-first expectations across the portfolio, and ensuring safe experimentation, validation and governance of AI outputs.
• Own delivery end-to-end — sequencing increments to validate value hypotheses fast; contracting vendors on outcomes and holding internal and external teams to account for quality, speed and value.
• Embed quality and compliance — applying GxP, privacy and AI-governance considerations from the start, maintaining good hygiene in core systems of record, and closing risks and issues in a timely manner.
• Partner, influence and mentor — building trusted relationships with senior Regulatory, Clinical and Medical stakeholders, staying aligned with peer Product Owners and Product Directors, and coaching junior Product Owners to build a high-performing, autonomous team.

Skills

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

Education

Bachelor’s degree or equivalent in scientific/technical discipline

Job description

Our approach to R&D

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. We’re uniting science, technology, and talent to get ahead of disease together.

Position Summary

As Senior Product Owner for Regulatory Intelligence & Health Authority Engagement, you are accountable for the digital products that support GSK’s regulatory intelligence, health authority engagement and transparency processes within the Evidence Presentation & Regulatory portfolio. Sitting within R&D Digital & Technology, you translate the needs of Regulatory Affairs, Clinical and wider R&D into coherent user requirements — ensuring regulatory teams have timely intelligence, structured insight and seamless tools to manage interactions with agencies such as the FDA, EMA, MHRA and PMDA. You represent technology for the Regulatory Intelligence workstream within a major strategic program, drive the roadmap for capabilities that manage HA questions, correspondence and insight, mentor other Product Owners, and role-model GSK’s values — Ambitious for patients, Accountable for impact, Do the right thing.

Responsibilities

• Set the product vision and roadmap for Regulatory Intelligence & Health Authority Engagement, articulating how technology and AI improve regulatory success, HA interactions and transparency — with value-grounded prioritization, investment and sequencing aligned to DevCMO strategy.
• Connect the portfolio — connecting Regulatory Intelligence & Engagement with the Medical and Regulatory Content Lifecycle and other DevCMO portfolios to form a unified, data-centric digital ecosystem.
• Bring domain expertise in regulatory intelligence, HA engagement and transparency processes — spotting bottlenecks and opportunities across the submissions, evidence and disclosure lifecycle, and co-designing simple, compliant user journeys with design and engineering.
• Shape sound technical solutions with architects and engineers — shaping technical trade-offs, designing sound solutions and bringing emerging technology in where it creates value.
• Champion an AI-first approach — using AI as a default tool to prototype, draft and decide, setting AI-first expectations across the portfolio, and ensuring safe experimentation, validation and governance of AI outputs.
• Own delivery end-to-end — sequencing increments to validate value hypotheses fast; contracting vendors on outcomes and holding internal and external teams to account for quality, speed and value.
• Embed quality and compliance — applying GxP, privacy and AI-governance considerations from the start, maintaining good hygiene in core systems of record, and closing risks and issues in a timely manner.
• Partner, influence and mentor — building trusted relationships with senior Regulatory, Clinical and Medical stakeholders, staying aligned with peer Product Owners and Product Directors, and coaching junior Product Owners to build a high-performing, autonomous team.

Basic Qualifications

• Bachelor’s degree or equivalent experience in a scientific, technical or related discipline (e.g. life sciences, computer science, engineering).
• ~5+ years in digital product management or product ownership across progressively senior roles, including backlog management and iterative delivery — enough to independently own the vision, roadmap and prioritization for a workstream of this scale.
• Experience in pharmaceutical R&D, clinical development or regulatory affairs, with direct exposure to regulatory submissions or health authority engagement.

Preferred Qualifications

• Hands-on experience with regulatory intelligence tools (e.g. Cortellis, IQVIA, Freyr), HA Q&A / correspondence management, submissions tracking or transparency and disclosure solutions.
• Experience leading technology workstreams within a larger program, such as digital transformation in a large enterprise.
• Familiarity with AI / ML solutions in regulated environments and the associated validation and governance requirements.
• Proven ability to work in global, matrixed organizations and influence cross-functional teams.

Skills

• 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

Why GSK?

Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [e-mail] where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide.

If you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit https://openpaymentsdata.cms.gov/.

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