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Latam Regulatory Affairs Coordinator

hace 3 meses

Bogotá, Bogotá D.E., Colombia SGF Global A tiempo completo

Role description

  • Coordinate the Regulatory Affairs activities at the export markets (Ecuador, Peru, Venezuela, Bolivia, Paraguay and Uruguay)
  • Implement and execute Regulatory Affairs processes and policies ensuring that all the aspects of the product safety are closely monitored and fulfil the regulatory requirements through ongoing support and solutions
  • Contribute to developing regulatory activities on both new and inline products in accordance with health authorities to define registration plans to meet business needs.
  • Track the alignment of the Regulatory Affairs activities like preparation, submission and followup of medical affairs, authorities (MAA) and registration files and reconcile any deviation from plans and processes
  • Implement, execute, and maintain the programs and policies ensuring the organization is aware of and compliant with legislation and regulations pertaining to the business
  • Contribute to the development and administration of all processes related to Regulatory Affairs Generalists programs and policies, monitoring/interpreting regulatory developments and determining the impact on business operations and compliance programs
  • Collaborate with other teams of Regulatory Affairs on compliance implementation, regulatory reporting/documentation for internal and external audiences; to support all stakeholders
  • Participate in driving transformation and change by gathering data, preparing, reviewing, and/or approving regulatory compliance documents to maximize effectiveness and efficiency