Project Manager (Regulatory Information Management (RIM))

Smartedge’s Client is looking for an individual to help with their Project Manager – Regulatory Information Management (RIM) @ Remote Working Key area:The Governance Business Program Project Manager will lead and manage large-scale Regulatory Information Management (RIM) programs, supporting global regulatory operations across the product lifecycle. The role focuses on governance, program delivery, system implementation, data migration, compliance, and stakeholder management within a regulated life-sciences environment.Key ResponsibilitiesProgram & Project ManagementLead end-to-end delivery of governance-driven business programs related to Regulatory Information Management (RIM).Plan, track, and manage regulatory activities across the drug lifecycle and submission operations.Coordinate multiple workstreams ensuring adherence to timelines, scope, quality, and compliance.Drive cross-functional collaboration across business, IT, vendors, and senior stakeholders.RIM / Vault ImplementationLead solution design and implementation of Veeva Vault Regulatory suite (Registrations, Submissions, Submissions Archive, Publishing).Conduct requirement gathering workshops and harmonize functional requirements with SMEs.Ensure configuration, documentation, validation, functional and user acceptance testing (UAT).Data Migration & GovernanceLead end-to-end data and content migration including data mapping, transformation, enrichment, and data quality validation.Define and implement naming conventions, reference data, master data, and migration standards.Develop and maintain end-to-end migration strategy and documentation.Compliance & QualityAct as subject matter expert on regulatory compliance and computer system validation (CSV).Ensure compliance with 21 CFR Part 11 and global regulatory submission standards.Develop and maintain SOPs, WIs, QRGs, and governance documentation.Identify and mitigate risks related to quality, compliance, and delivery.Stakeholder & Team LeadershipCommunicate complex regulatory and technical information clearly to senior stakeholders.Mentor and guide project team members and consultants.Support resource planning and delivery capacity management.Continuous ImprovementIdentify process efficiencies and system improvements in RIM operations.Contribute to continuous improvement initiatives and key user forums as RIM SME.Required Experience & SkillsStrong experience in Regulatory Information Management (RIM) within Life Sciences / Pharmaceuticals.Proven program and project management experience in global regulatory environments.Hands-on experience with Veeva Vault Regulatory suite implementations.Expertise in data governance, migration, and data quality management.Strong understanding of global regulatory compliance and submission processes.Excellent communication and stakeholder management skills.Ability to work independently in a global, matrix organization.If this sounds like a role you would be interested in or if you know someone in this field.Connect with me or email me at sirisha.p@smartedgesolutions.co.ukAlternatively, you can call me on Tel: +44(0)203 500 2108.