Overview
In this role you drive the vision and roadmap for Regulatory Vault (Veeva RIM) to streamline regulatory processes within GSK’s R&D. You partner with cross-functional teams and an MSP to shape features, define requirements, and coordinate delivery. You will build domain knowledge of regulatory workflows and ensure solutions meet regulatory and business needs while influencing the Veeva ecosystem. The position offers impact on submission cycle times and quality across many markets, with a focus on scalable, compliant SaaS solutions.
Responsibilities
- Define and maintain the Regulatory Vault backlog and roadmap aligned with 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; escalate and unblock issues as needed
Key requirements
- 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
- collaboration
- communication
- stakeholder management
- Veeva RIM
- regulatory processes and systems
- SaaS/configurable-off-the-shelf products
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