Sr Product Owner, Regulatory Intelligence & HA Engagement

GSK

Irvine

On-site

GBP 85,000 - 110,000

Full time

6 days ago

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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.