Senior Specialist: Study Start-Up & Regulatory Affairs

31 ago - Lazio
Ergomed Group

Ergomed Group in Italy seeks a Senior Specialist, Study Start Up and Regulatory Affairs to lead activities ensuring site initiation readiness across studies.
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You will provide subject matter expertise, manage regulatory submissions, and liaise with internal teams, clients and external stakeholders.
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Key duties include delivering regulatory milestones, drafting and reviewing essential documents, site agreements, translations, and ensuring compliance with ICH-GCP and country-specific requirements.
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