W3Global
Senior Business Analyst
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Business Analyst
London, UK
Contract
Hybrid - 2-3 days a week.
Senior Business Analyst - Regulatory Experience
12-15 years in pharma regulatory affairs, regulatory operations, or RIM/submissions consulting
ABOUT THE ROLE
Our client (Life Sciences & Healthcare practice) is seeking a Principal Consultant to lead regulatory affairs business analysis on Regulatory Information Management (RIM) and submissions-focused engagements for global pharmaceutical clients. This is a senior domain BA role for someone who has worked inside a pharma regulatory affairs or regulatory operations function, a CRO, or a RIM systems integrator, and can act as the trusted bridge between Regulatory Affairs business stakeholders and IT/platform delivery teams.
You will own requirements and process design for RIM and submission-publishing programmes - most commonly built on Veeva Vault RIM - translating global regulatory processes and health authority requirements into system requirements, data models, and validated solutions.
KEY RESPONSIBILITIES
- Lead requirements gathering, process mapping, and gap analysis for Regulatory Information Management engagements - Registrations, Submissions, Submissions Archive, and Publishing (Veeva Vault RIM or equivalent platforms such as ArisGlobal, Extedo, Generis CARA).
- Act as the primary liaison between Regulatory Affairs/Operations business stakeholders and IT/platform implementation teams, translating regulatory business needs into functional specifications and configuration requirements.
- Facilitate requirements and design workshops with client regulatory, quality, and IT stakeholders; document current-state and future-state process flows, user stories, and business/functional requirements (BRD/FRD/URS).
- Support IDMP/SPOR readiness and regulatory data standardization workstreams - data mapping, cleansing, and enrichment against global regulatory data standards.
- Own requirement traceability across the delivery lifecycle - from requirements through configuration, validation (CSV), UAT, and go-live - ensuring alignment with GxP and computer system validation expectations.
- Author and review supporting documentation (SOPs, work instructions, training materials, validation deliverables) to embed new RIM processes into business-as-usual operations.
- Support the wider regulatory affairs advisory team on client engagements, including submission-lifecycle process improvement, regulatory operating model design, and health-authority (MHRA/EMA/FDA) process alignment.
- Contribute to proposal development and reusable accelerators (requirements templates, process libraries, RIM configuration playbooks) for the Regulatory Affairs advisory practice.
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MUST-HAVE QUALIFICATIONS
- 12-15 years of overall experience, with a minimum of 6-8 years directly in pharmaceutical regulatory affairs, regulatory operations, or regulatory information management - gained at a pharma manufacturer, CRO (e.g., IQVIA, Parexel, ICON), a RIM systems integrator, or an IT/domain consulting firm (e.g., Accenture, Cognizant, Deloitte, Capgemini).
- Hands-on business analysis experience on a Regulatory Information Management platform - Veeva Vault RIM (Registrations, Submissions, Publishing, Archive) strongly preferred; exposure to ArisGlobal, Extedo, Generis CARA, or legacy Documentum-based RIM tools also relevant.
- Strong understanding of global regulatory submission processes, dossier lifecycle management, and health authority requirements (MHRA, EMA, FDA).
- Demonstrated experience gathering and documenting business/functional requirements (BRD/FRD/URS, user stories), facilitating workshops, and building process maps (as-is/to-be, BPMN or swim-lane).
- Working knowledge of IDMP/SPOR data standards and regulatory data governance considerations.
- Experience operating in GxP-regulated environments, including familiarity with computer system validation (CSV) principles and documentation.
- Excellent stakeholder management and communication skills; able to act as a credible bridge between regulatory business stakeholders and technical delivery teams.
- Life sciences, pharmacy, or related scientific/business degree.
- Based in or willing to relocate to the UK, with flexibility to travel to client sites across the UK/EU as required.
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NICE-TO-HAVE / PREFERRED:
- Veeva Vault RIM configuration or implementation certification, or direct experience on a Vault RIM implementation/migration programme.
- Exposure to regulatory process mining or digital-twin approaches to submission process redesign.
- Experience with Agile delivery practices (Jira, Confluence) in a regulated life sciences context.
- CCDM/CCDS or equivalent regulatory/clinical data management certification.
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