Business Compliance Strategist

Há 2 dias

Ituiutaba, Brasil Bebeecompliance Tempo inteiro

Regulatory Affairs Specialist Job DescriptionThe Regulatory Affairs Specialist will play a pivotal role in enhancing compliance, efficiency, and reporting within our organization.
This individual will work closely with cross-functional stakeholders to identify and recommend improvements to business processes, regulatory data, and data definitions for the RIM platform.Responsibilities:Support efforts to align business processes with a RIM enterprise data strategy by collaborating with Global Regulatory Operations (GRO), Global Regulatory Affairs (GRA), and other stakeholders.Contribute to end-to-end RIM implementation, including new system implementation, change requests, upgrades, integrations, data quality, metrics, and reporting.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.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:This position requires a strong background in Regulatory Affairs Operations, preferably in the biotechnology or pharmaceutical industry.
The ideal candidate should have experience in systems management or implementation in the life sciences industry or regulated industry.6+ years of experience in working in a Regulatory Affairs Operations environment.Experience in Veeva Vault RIM is mandatory.Other system experience preferred and may include Calyx, Lorenz, Integras, SPORIFY, and other Veeva Vaults (PromoMat, eTMF, Quality).
Proficiency in Microsoft Office and Adobe systems.Knowledge of regulations, processes, and industry standards and best practices that govern regulated systems, records retention, and GxP.Key Requirements:To succeed in this role, you should possess strong analytical and problem-solving skills, excellent communication and interpersonal skills, ability to work independently and as part of a team, strong attention to detail and organizational skills, and proficiency in Microsoft Office and Adobe systems.

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