Regulatory Affairs Specialist

4 semanas atrás

Brasília, Brasil Insight Global Tempo inteiro

Job Description:

The position will have primary responsibility in the Global Development Information Management team. A key responsibility of this role is to identify and recommend improvements to business processes, regulatory data, and data definitions for the RIM platform, while working in close collaboration with Global Regulatory Operations (GRO), Global Regulatory Affairs (GRA) and cross-functional stakeholders (e.g., IT, Clinical, Nonclinical, Quality). Identify opportunities within the RIM platform, to enhance compliance, efficiency, and reporting. Responsible for supporting RIM Reporting and Analytics needs across Global Regulatory Affairs as needed.

Responsibility:

  • Support efforts to align business processes to a RIM enterprise data strategy.
  • Contribute to implementation of E2E RIM which includes new system implementation, change requests, upgrades, integrations, data quality, metrics & reporting, etc.
  • Ensure user’s 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 Experience:

  • 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.
  • Must have experience in Veeva Vault RIM
  • Other system experience preferred and may include Calyx, Lorenz, Integras, SPORIFY, and other 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


Compensation: $15/hour - $25/hr USD

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