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. 
  

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.