Product Owner, Regulatory Intelligence and Engagement

Responsibilities

• This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
• 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.
• Why You?

Requirements

• We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
• 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.
• If you have the following characteristics, it would be a plus:
• 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.
• #GSK-LI
• 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 thr

Benefits

Additional Information

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. Find out more: Our approach to R&D 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 .

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