Regulatory Data Governance Expert
Há 24 horas
Regulatory Affairs SpecialistThe Global Regulatory Information Management team is seeking an expert in regulatory affairs.
The ideal candidate will have experience in identifying process improvements, enhancing regulatory data, and defining data models for the RIM platform.Key Responsibilities:Align business processes with a RIM enterprise data strategy.Contribute to end-to-end RIM implementation, including new system implementations, change requests, upgrades, integrations, data quality, metrics, and reporting.Document user requirements and serve as the basis for system continuous improvement, process engineering/mapping, and/or new system selection.Provide training and support for 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 a roadmap for addressing them.Required Skills and Experience:At least 6 years of experience working in biotechnology or pharmaceutical regulatory affairs operations environments.Experience in systems management or implementation in the life sciences industry or regulated industries.Must have experience in Veeva Vault RIM.Other system experience preferred: Calyx, Lorenz, Integras, SPORIFY, Veeva Vaults (PromoMat, eTMF, Quality).
Microsoft Office and Adobe systems.Knowledge of regulations, processes, and industry standards and best practices that govern regulated systems, records retention, and GxP.Benefits:A dynamic work environment with opportunities for growth and development.A competitive salary and benefits package.The chance to work with a talented team of professionals.Others:This position requires a strong understanding of regulatory affairs and the ability to work effectively in a team environment.The ideal candidate will have excellent communication and problem-solving skills.
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