Biotech Regulatory Systems Manager
Há 7 horas
Job DescriptionThis position will play a pivotal role in shaping and implementing business processes, regulatory data, and data definitions for the RIM platform.
The ideal candidate will possess exceptional analytical skills, enabling them to identify areas for improvement and recommend effective solutions.Key Responsibilities:Strategize and implement improvements to business processes, regulatory data, and data definitions for the RIM platform.Support the alignment of business processes with a RIM enterprise data strategy.Promote the implementation of E2E RIM, encompassing 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.Develop and deliver training programs and support change management activities in RIM implementation and upgrades.Monitor and track the 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.Analyze emerging structured data standards or health agency requirements, assess their impact on the business, and define a roadmap for addressing them.Required Skills and Qualifications:6+ years of experience working in a biotechnology or pharmaceutical Regulatory Affairs Operations environment.Proven experience in systems management or implementation in the life sciences industry or regulated industry.Mandatory experience in Veeva Vault RIM.Other system experience preferred, including Calyx, Lorenz, Integras, SPORIFY, and other Veeva Vaults (PromoMat, eTMF, Quality).
Proficiency in Microsoft Office and Adobe systems.In-depth knowledge of regulations, processes, and industry standards and best practices governing regulated systems, records retention, and GxP.Benefits:This role offers an exciting opportunity to contribute to a dynamic team and grow professionally in a fast-paced environment.About this Role:The successful candidate will be an excellent communicator, able to effectively collaborate with cross-functional teams and stakeholders to drive business outcomes.
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