Job Title

Job Summary:We are looking for an experienced Regulatory Business Analyst with strong hands-on experience in Veeva Vault RIM to support regulatory operations and digital transformation initiatives within the pharmaceutical domain. The ideal candidate should have a deep understanding of regulatory processes and documentation, and be capable of working closely with regulatory affairs teams, IT, and vendors to drive system implementation and optimization.Key Responsibilities:Gather and document business and functional requirements related to regulatory systems and workflows.Act as a liaison between Regulatory Affairs and IT teams, translating business needs into actionable system enhancements.Drive implementation and optimization of Veeva Vault RIM modules: Submissions, Registrations, Submissions Archive, and Product.Analyze existing regulatory processes and recommend digitization/improvement opportunities.Support data migration, configuration, validation, and user acceptance testing (UAT) of Veeva Vault RIM.Document BRD, FRD, use cases, process flows, and traceability matrices.Ensure compliance with global regulatory requirements (e.g., FDA, EMA, ICH).Work in collaboration with cross-functional teams (Quality, RA Ops, IT, Vendors) across geographies.Required Skills & Qualifications:6+ years of experience as a Business Analyst in the Pharmaceutical or Life Sciences domain.Minimum 2 years hands-on experience in Veeva Vault RIM (Submissions/Registrations/Product modules).Strong understanding of Regulatory Affairs processes: submission lifecycle, labeling, lifecycle management, compliance.Proven experience in requirement gathering, documentation, and stakeholder management.Familiarity with eCTD, IDMP, XEVMPD, and GxP compliance.Experience with CSV/validation support is a plus.Excellent communication, presentation, and analytical skills.Nice-to-Have:Experience with other regulatory systems (e.g., ArisGlobal, Lorenz docuBridge, MasterControl).Exposure to Agile/Scrum methodologies.Knowledge of Veeva Vault Quality or PromoMats is a bonus.