Senior Regulatory Transformation / Programme Advisory Lead

Overview

We are looking for a senior Regulatory Transformation / Programme Advisory professional to support a major pharmaceutical regulatory transformation programme involving Veeva Vault RIM, legacy-system replacement, data migration, validation and release readiness.

The consultant will provide 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.
  
• Review and assess integrated programme planning, milestones and critical path.
  
• Identify and assess cross-workstream dependencies, blockers and delivery risks.
  
• Produce RAID assessments covering Risks, Assumptions, Issues and Dependencies.
  
• Assess planning gaps and recommend corrective actions.
  
• Provide executive and SteerCo-level decision-support materials.
  
• Assess change requests and their potential impact on schedule, cost, quality and dependencies.
  
• Support assessment of Veeva Vault RIM implementation approaches.
  
• Assess programme readiness across Business, IT, System Integrators, data, validation and deployment.
  
• Provide cutover and release-readiness assessments.
  
• Support hypercare and stabilisation assessments.
  
• Work closely with Regulatory Affairs, IT, System Integrators and technology partners.
  
• Provide recommendations and structured assessments rather than taking operational ownership.
  

Requirements

Essential Experience

• Senior-level experience delivering or advising on large-scale transformation programmes within pharmaceutical/life sciences.
  
• Strong regulatory transformation experience.
  
• Experience working across Business, IT, System Integrators and technology vendors.
  
• Experience with complex enterprise transformation programmes.
  
• Strong experience producing RAID, dependency, planning and executive-level assessments.
  
• Experience supporting governance/SteerCo environments.
  
• Experience with release readiness, cutover and go-live.
  
• Strong understanding of GxP environments and pharmaceutical technology quality requirements.
  
• Experience with data migration and legacy-system transformation.
  
• Experience with Agile/Scrum/SAFe and tools such as Smartsheet and Jira.
  
• Strong commercial understanding, including budgets, business cases and vendor considerations.
  
• Strong analytical and consulting skills
  

Desirable

• Previous Novartis experience.
  
• Freeway or comparable regulatory-platform transformation experience.
  
• Experience with eCAR, ICE or comparable governance/investment methodologies.
  
• Veeva Vault RIM programme experience. 
  

On-site Requirement

Must be able to attend Basel during defined critical phases, including planning, governance, validation, cutover and go-live. 

Ideal Background

Senior Programme Advisor / Transformation Lead / Regulatory Transformation Consultant / Programme Assurance Lead with significant pharmaceutical transformation experience.