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: Enjoy flexible working, competitive salary, and opportunities for professional growth.
- Other info: Collaborate with top professionals in a dynamic, supportive environment.
- 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 required.
The predicted salary is between 60000 - 80000 £ 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. 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.
- 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.
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.
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.
Product Owner, Regulatory Intelligence and Engagement employer: GlaxoSmithKline
At GSK, we are committed to fostering a dynamic and inclusive work environment where innovation thrives. As a Product Owner in Regulatory Intelligence and Engagement, you will have the opportunity to lead impactful projects that directly contribute to our mission of improving global health. With a strong focus on employee development, cutting-edge technology, and a culture that prioritises accountability and ambition for patients, GSK offers a unique platform for professionals to grow and make a meaningful difference in the biopharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Product Owner, Regulatory Intelligence and Engagement
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We think you need these skills to ace Product Owner, Regulatory Intelligence and Engagement
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at GlaxoSmithKline!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show GlaxoSmithKline that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at GlaxoSmithKline!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At GlaxoSmithKline, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at GlaxoSmithKline
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at GlaxoSmithKline that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with GlaxoSmithKline’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
