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 clients 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.
  

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.
  

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.