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Specialist/Snr Specialist Study Start Up and Regulatory Affairs

πŸ•’ 10 days ago
Regulatory ComplianceClinical ResearchProject ManagementDocumentation Review

πŸ“œ Description

  • Leads and coordinates activities for achieving site initiation readiness.
  • Provides subject matter expertise and ensures regulatory compliance.
  • Acts as a key liaison between internal teams, clients, and external stakeholders.
  • Handles medium-complexity regulatory environments and multi-country requirements.
  • Leads preparation, review, and quality control of regulatory documentation.
  • Identifies and escalates risks that may jeopardize project deliverables.

πŸ› οΈ Requirements

  • Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience
  • Minimum 4 years within pharmaceutical or CRO industry or Regulatory body
  • Good knowledge of ICH GCP and national regulations for territories of competency
  • Good understanding of specific country requirements pertaining to SSU/Regulatory delivery in multiple countries within Europe and/or the Americas
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