At a Glance
- Tasks: Lead digital products for regulatory intelligence and health authority engagement at GSK.
- Company: Join GSK, a global biopharma company with a mission to impact 2.5 billion lives.
- Benefits: Flexible working culture, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on AI and cutting-edge technology.
- Why this job: Make a real difference in healthcare by driving innovation in regulatory processes.
- Qualifications: Bachelor's degree and 5+ years in digital product management or ownership.
The predicted salary is between 63000 - 77000 £ per year.
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.
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 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.
- 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.
- 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.
- 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.
- Partner, influence and mentor — building trusted relationships with senior Regulatory, Clinical and Medical stakeholders.
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.
- Experience in pharmaceutical R&D, clinical development or regulatory affairs.
Preferred Qualifications
- Hands-on experience with regulatory intelligence tools (e.g. Cortellis, IQVIA, Freyr).
- Experience leading technology workstreams within a larger program.
- Familiarity with AI / ML solutions in regulated environments.
- Proven ability to work in global, matrixed organizations and influence cross‑functional teams.
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 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.
Product Owner, Regulatory Intelligence And Engagement in England employer: GlaxoSmithKline plc
GSK is an exceptional employer that fosters a culture of innovation and collaboration, making it an ideal place for professionals seeking to make a meaningful impact in the biopharma industry. With a commitment to employee growth through continuous learning opportunities and a flexible hybrid working model, GSK empowers its workforce to thrive while contributing to groundbreaking advancements in healthcare. Located in vibrant London, employees benefit from a dynamic work environment that prioritises ambition for patients and accountability for results.
StudySmarter Expert Advice🤫
We think this is how you could land Product Owner, Regulatory Intelligence And Engagement in England
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We think you need these skills to ace Product Owner, Regulatory Intelligence And Engagement in England
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