Senior Regulatory Transformation / Programme Advisory Lead
Core
Senior advisory professional supporting a major pharmaceutical regulatory transformation programme involving Veeva Vault RIM, legacy-system replacement, data migration, validation, and release readiness.
Role type
Senior IC regulatory transformation programme advisory lead
Builds
Independent advisory assessments, recommendations, and decision-support materials for senior Business and IT stakeholders
Domain
Life sciences / Pharmaceutical regulatory technology
Deliverable
client delivery
Required skills
Large-scale transformation programme delivery/advisory, regulatory transformation, cross-workstream dependency analysis, RAID assessment, executive decision support, GxP environment understanding, data migration, legacy-system transformation, Agile/Scrum/SAFe methodology, commercial budgeting and business cases
Preferred skills
Novartis experience, Freeway platform transformation, eCAR/ICE governance methodologies, Veeva Vault RIM programme experience
Technologies
Veeva Vault RIM, Smartsheet, Jira
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
Seniority
Senior, hands-on IC
