Product Manager - Regulatory Vault

GSK; Greater London; On-site; GBP 90,000 - 120,000; Full time

Job summary

GlaxoSmithKline (GSK) invites you to join our R&D Digital and Tech Team as a Product Manager - Regulatory Vault. You will drive the vision and roadmap for GSK's Regulatory Vault (Veeva RIM) to streamline regulatory processes across 160 markets.

You will partner with business owners in R&D and other functions, map user journeys, define requirements, and coordinate delivery with the MSP. Experience with regulatory processes and Veeva RIM is important; you will shape product leadership and

Qualifications

• Bachelor's degree or comparable experience in computer science, life sciences, regulatory affairs, or related discipline.
• Experience delivering IT-enabled solutions in a life sciences or regulated environment, including product ownership, business analysis, or project delivery.
• Practical experience or familiarity with regulatory processes and systems; experience with Veeva RIM is highly desirable.
• Strong collaboration, communication, and stakeholder management skills.
• Veeva white belt or other relevant Veeva training (desirable).
• Experience with submission publishing (eCTD/non-eCTD), Regulatory Intelligence tools, or RIM integrations.
• Experience working with SaaS/configurable-off-the-shelf products and managed service partners.
• Experience in GxP contexts or familiarity with Risk, QA or Audit teams is advantageous.

Responsibilities

• Define and maintain the product backlog and roadmap for Regulatory Vault features aligned to stakeholder needs.
• Elicit, document and prioritise requirements, user stories, and acceptance criteria.
• Coordinate with the Managed Service Provider, internal IT, and business stakeholders to deliver features iteratively.
• Support testing, release readiness, and change management to adoption.
• Build domain knowledge of GSK R&D medicines and vaccines regulatory processes and contribute to product strategy.
• Ensure delivered solutions comply with internal security, risk, and external regulatory expectations.
• Provide input to vendor relationships and configuration choices.

Skills

Agile methodology

Backlogs

Cross-functional teamwork

Design thinking

DevOps

Requirements gathering

User experience (UX)

User research

Education

Bachelor's degree or comparable experience in computer science, life sciences, regulatory affairs, or related discipline

Tools

Veeva RIM

Job description

Are you passionate about making impactful contributions to the world of medicines and vaccines? GlaxoSmithKline (GSK) invites you to join our dynamic R&D Digital and Tech Team as a Product Manager - Regulatory Vault. In this pivotal role, you will drive the vision and roadmap for the evolution of GSK's Regulatory Vault (Veeva RIM), ensuring our regulatory processes are streamlined and efficient. As Product Manager - Regulatory Vault you will partner with business owners across R&D and other functions to shape product vision, prioritize work, and coordinate delivery with our Managed Service Provider. You will map user journeys, define requirements, and ensure features are configured and delivered to meet regulatory and business needs. Practical experience with regulatory processes and Veeva RIM (or similar RIM systems) is important; you will develop your product leadership skills while influencing configurable SaaS solutions. At GSK R&D, we are driven by an ambitious goal to expedite submission cycle times and enhance submission quality across over 160 markets. Our investment in a cutting-edge Veeva RIM-based Regulatory Vault is a testament to our commitment to excellence. This platform is an integral part of a comprehensive Veeva ecosystem, supporting the entire development process. GSK stays dedicated to influencing Veeva's roadmap and extracting maximum value from our investments.,

• Define and maintain the product backlog and roadmap for Regulatory Vault features aligned to stakeholder needs.
• Elicit, document and prioritise requirements, user stories, and acceptance criteria.
• Coordinate with the Managed Service Provider, internal IT, and business stakeholders to deliver features iteratively.
• Support testing, release readiness, and change management to adoption.
• Build domain knowledge of GSK R&D medicines and vaccines regulatory processes and contribute to product strategy.
• Ensure delivered solutions comply with internal security, risk, and external regulatory expectations.
• Provide input to vendor relationships and configuration choices; escal...
  Bachelor's degree or comparable experience in computer science, life sciences, regulatory affairs, or related discipline.
• Experience delivering IT-enabled solutions in a life sciences or regulated environment, including involvement in product ownership, business analysis, or project delivery.
• Practical experience or familiarity with regulatory processes and systems; experience with Veeva RIM is highly desirable.
• Strong collaboration, communication, and stakeholder management skills., Veeva white belt or other relevant Veeva training (desirable).
• Experience with submission publishing (eCTD/non-eCTD), Regulatory Intelligence tools, or RIM integrations.
• Experience working with SaaS/configurable-off-the-shelf products and managed service partners.
• Experience in GxP contexts or familiarity partnering with Risk, QA or Audit teams is advantageous.
• Data-driven mindset and focus on delivering business value and simplification., Agile Methodology, Backlogs, Cross-Functional Teamwork, Design Thinking, DevOps, Process Diagrams, Product Strategies, Project Management, Requirements Gathering, Services Management, Software Development, User Experience (UX), User Research, User Story
  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 thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. 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. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [e-mail] where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov