Director of Regulatory Affairs

1 giorno fa


roma, Italia Barrington James A tempo pieno

The Regulatory Business Partner is a senior, client-facing consultant responsible for leading digital regulatory transformation initiatives for life sciences clients. The role requires a strong combination of regulatory domain expertise, technology leadership, and commercial consulting capability.You will partner closely with Regulatory Affairs, Regulatory Operations, IT, and Quality teams, providing strategic input while overseeing the delivery of regulatory systems, data, and operating model transformations.Key ResponsibilitiesAct as a trusted advisor to senior Regulatory and IT stakeholdersLead delivery of complex regulatory transformation programmesProvide oversight across scope, timelines, quality, and complianceLead implementation and optimisation of Veeva RIM solutions (Registrations, Submissions, IDMP, Labeling)Support regulatory data management and governance initiativesOversee regulatory data migration from legacy systems to modern platformsDefine and improve digital and automated regulatory processesDevelop and expand client relationships, identifying new business opportunitiesLead pre-sales activities, including discovery sessions, demos, and RFI/RFP responsesContribute to and own Statement of Work (SOW) creationRequired Skills & Experience10+ years’ experience in Regulatory Affairs, Regulatory Operations, Regulatory IT, or consultingStrong experience in digital regulatory transformationProven hands-on experience with Veeva RIM (mandatory)Strong IT, systems, and data management capabilityExperience leading data migration and system modernisation initiativesExposure to Oracle-based environments (highly desirable)Background in IT or Engineering preferredCertifications (Highly Desirable)Regulatory or agile delivery certifications#J-18808-Ljbffr



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