28 may
|
Sgf Global
|
Bogotá
Postúlate en Kit Empleo: kitempleo.com.co/empleo/1asegf
**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 in-line 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 follow-up 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
Postúlate en Kit Empleo: kitempleo.com.co/empleo/1asegf
📌 Latam Regulatory Affairs Coordinator (Bogotá)
🏢 Sgf Global
📍 Bogotá