Description
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.
You will 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.
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.
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.
- Experience in pharmaceutical R&D, clinical development or regulatory affairs, with direct exposure to regulatory submissions or health authority engagement.
Benefits
- GSK offers an agile working culture for all roles.
- The company provides equal opportunities for employment and encourages diversity.