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1 semana atrás
Job Title: Regulatory Affairs SpecialistJob Description:This role has primary responsibility in the Global Development Information Management team.
Key responsibilities include identifying and recommending improvements to business processes, regulatory data, and data definitions for the RIM platform while collaborating with cross-functional stakeholders.Achieving compliance, efficiency, and reporting are key objectives.
Supporting RIM Reporting and Analytics needs across Global Regulatory Affairs is essential.Responsibilities:Align business processes to a RIM enterprise data strategy.Contribute to the implementation of E2E RIM which includes new system implementation, change requests, upgrades, integrations, data quality, metrics & reporting, etc.Ensure user requirements are adequately documented and serve as the basis for system continuous improvement, process engineering/mapping, and/or new system selection.Conduct training and support change management activities in RIM implementation and upgrades.Track alignment of business processes and models across all business functions supporting global Regulatory product registrations.Lead and/or support initiatives to integrate Regulatory information and records globally and for acquired assets and products.Monitor emerging structured data standards or health agency requirements, assess business impact, and define roadmap for addressing them.Required Skills and Qualifications:This role requires 6+ years of experience in working in a biotechnology or pharmaceutical Regulatory Affairs Operations environment.
Experience in systems management or implementation in the life sciences industry or regulated industry is essential.Veeva Vault RIM experience is a must.Other system experience preferred and may include Calyx, Lorenz, Integras, SPORIFY, and other Veeva Vaults (PromoMat, eTMF, Quality).
Microsoft Office and Adobe systems knowledge is required.Knowledge of regulations, processes, and industry standards and best practices that govern regulated systems, records retention, and GxP is crucial.Benefits:This role offers a competitive hourly rate between $15/hour - $25/hr USD.Why this role?
This role offers opportunities to work on innovative projects, collaborate with cross-functional teams, and contribute to the development of regulatory affairs operations.
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