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Specialist/Snr Specialist Study Start Up and Regulatory Affairs

🕒 9 days ago
Regulatory ComplianceClinical ResearchStudy Start-upDocumentation Review

📜 Description

  • Accountable for delivery of assigned study start-up and regulatory milestones within defined scope.
  • Makes independent decisions regarding regulatory processes and documentation approaches.
  • Handles medium-complexity regulatory environments, including multi-country requirements.
  • Leads preparation, review, and quality control of regulatory and study start-up documentation.
  • Responsible for drafting, negotiating, and executing clinical site agreements and amendments.
  • Provides regulatory strategic input and develops regulatory strategy and SSU Plan.

🛠️ 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
🕒 9 days ago

The Senior Specialist in Study Start Up and Regulatory Affairs leads site initiation readiness, ensuring regulatory compliance and serving as a liaison among teams and stakeholders.

Regulatory ComplianceClinical ResearchStudy Start-upDocumentation Review
🕒 9 days ago

The Senior Specialist in Study Start Up and Regulatory Affairs leads site initiation readiness, ensuring compliance and serving as a liaison between teams and stakeholders.

Regulatory ComplianceClinical ResearchStudy Start-upDocumentation Review
🕒 9 days ago

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the.

Regulatory ComplianceClinical ResearchStudy Start-upDocumentation Review
🕒 9 days ago

The Senior Specialist in Study Start Up and Regulatory Affairs leads site initiation readiness, ensuring compliance and serving as a liaison among teams and stakeholders.

Regulatory ComplianceClinical ResearchStudy Start-upDocumentation Review
🕒 9 days ago

The Senior Specialist in Study Start Up and Regulatory Affairs leads site initiation readiness, ensuring regulatory compliance and coordinating activities across internal teams and external stakeholders.

Regulatory ComplianceClinical ResearchStudy Start-upDocumentation Review

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