£450 per day
Outside Spy
United Kingdom
Clinical Regulatory Intelligence – Analyst / Consultant Leading pharmaceutical company require a consultant to help with clinical regulatory intelligence. Skills: Regulatory Intelligence platforms, Agile BA, Regulatory Affairs/Operations, submissions, eCTD, CMC Experience 5–9 years experience ( 4+ minimum ) in pharma / life sciences consulting or delivery Regulatory Affairs / Regulatory Operations experience Hands-on work with Regulatory Intelligence platforms Strong exposure to eCTD, submissions, labeling, CMC variations Understanding of Regulatory Intelligence lifecycle (capture → curate → consume Ability to independently lead a workstream and work directly with client stakeholders Business Analysis / Consulting skills Requirements gathering User stories Gap analysis & future-state design Agile delivery experience (mandatory) Experience with SaaS platform implementations Strong communication and stakeholder-management skills...