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ICON plc is seeking a Senior Manager of Regulatory Affairs to join their remote team in Bogota, Colombia. The role involves providing regulatory expertise in drug development, managing regulatory activities, and contributing to business development efforts within the clinical research sector.
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Job Summary
ICON plc is a world-leading healthcare intelligence and clinical research organization seeking a Senior Manager, Regulatory Affairs to join their diverse and dynamic team.
The role involves providing regulatory expertise in strategic drug development, preparing submission plans, and acting as an expert advisor to ICON clients.
ICON offers a competitive salary, a range of benefits focused on well-being and work-life balance, and is committed to providing an inclusive and accessible environment.
Matching Summary
Match Score: 75
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ICON plc is seeking a Senior Manager of Regulatory Affairs to join their remote team in Bogota, Colombia. The role involves providing regulatory expertise in drug development, managing regulatory activities, and contributing to business development efforts within the clinical research sector.
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Skills & Requirements
Must-have
regulatory expertise in drug development
preparation of submission plans
regulatory agency interactions
development of regulatory strategies
marketing authorization applications
clinical trials support
Nice-to-have
trusted partner for business development
expert advisor to clients
foster an inclusive environment
drive innovation and excellence
Key Requirements
Minimum 7 years regulatory affairs experience
Minimum 7 years pharmaceutical/CRO industry experience
Supervisory experience required
Demonstrable experience in regulatory strategy
Demonstrable experience in document writing
Demonstrable experience in marketing authorization applications
Demonstrable experience in clinical trials
Demonstrable experience in post-licensing activities
Demonstrable experience in direct regulatory agency interaction