Senior Regulatory Transformation / Programme Advisory Lead

About the role

A major pharmaceutical regulatory transformation programme involving Veeva Vault RIM, legacy-system replacement, data migration, validation and release readiness is seeking a senior Regulatory Transformation / Programme Advisory professional. The consultant provides independent advisory assessments, recommendations and decision-support materials to senior Business and IT stakeholders. This is an advisory role and does not involve taking ownership of the client's programme management or operational delivery.

Key responsibilities

• Provide independent assessments of programme delivery and execution health, including integrated planning, milestones and critical path
• Identify cross-workstream dependencies, blockers and delivery risks, and produce RAID assessments (Risks, Assumptions, Issues and Dependencies)
• Assess planning gaps and recommend corrective actions, and evaluate change requests against schedule, cost, quality and dependencies
• Support assessment of Veeva Vault RIM implementation approaches and programme readiness across Business, IT, System Integrators, data, validation and deployment
• Provide cutover and release-readiness assessments, and support hypercare and stabilisation assessments
• Produce executive and SteerCo-level decision-support materials and work with Regulatory Affairs, IT, System Integrators and technology partners

Required profile

• Senior-level experience delivering or advising on large-scale transformation programmes in pharmaceutical/life sciences
• Strong regulatory transformation experience and experience across Business, IT, System Integrators and technology vendors
• Experience with complex enterprise transformation programmes and governance/SteerCo environments
• Experience with release readiness, cutover and go-live, and data migration and legacy-system transformation
• Desirable: previous Novartis experience, Freeway or comparable regulatory-platform transformation experience, eCAR or ICE governance experience, and Veeva Vault RIM programme experience
• Must be able to attend Basel during defined critical phases, including planning, governance, validation, cutover and go-live

Required skills

• Strong understanding of GxP environments and pharmaceutical technology quality requirements
• Agile/Scrum/SAFe and tools such as Smartsheet and Jira
• Commercial understanding of budgets, business cases and vendor considerations
• Analytical and consulting skills