Regulatory Data Manager

Há 22 horas


Belo Horizonte, Brasil Bebeeregulatoryaffairs Tempo inteiro

Job Description:The role of the Regulatory Affairs Specialist involves leading improvements to business processes, regulatory data and RIM platform for the Global Development Information Management team.In collaboration with GRO, GRA, IT, Clinical, Nonclinical, Quality and cross-functional stakeholders, identify opportunities within the RIM platform to enhance compliance, efficiency and reporting.Key responsibilities include:Aligning business processes to a RIM enterprise data strategy.Implementing E2E RIM, including new system implementation, change requests, upgrades, integrations, data quality, metrics & reporting.Documenting user requirements and serving as basis for system continuous improvement and process engineering/mapping.Conducting training and supporting change management activities in RIM implementation and upgrades.Tracking alignment of business processes and models across all business functions supporting global Regulatory product registrations.Leading initiatives to integrate Regulatory information and records globally and for acquired assets and products.Monitoring emerging structured data standards or health agency requirements, assessing business impact and defining roadmap for addressing them.Required Skills and Qualifications:6+ years of experience in Regulatory Affairs Operations in biotechnology or pharmaceutical industry.Experience in systems management or implementation in life sciences industry or regulated industry.Veeva Vault RIM experience required.Other system experience preferred.Microsoft Office and Adobe systems.Knowledge of regulations, processes and industry standards and best practices that govern regulated systems, records retention and GxP.



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