4h ago

Regulatory and Start Up Specialist

Remote, Poland
J
full-timemid RemoteClinical Research Organization

🛠 Tech Stack

💼 About This Role

You'll manage site activation readiness for clinical trials, ensuring timely submissions to Competent Authorities and Ethics Committees. You'll collaborate with cross-functional teams to secure study approvals and maintain regulatory compliance. This role offers the chance to work remotely while impacting precision medicine.

🎯 What You'll Do

  • Prepare and submit Clinical Trial Application Forms and dossiers
  • Interact with Competent Authorities and Ethics Committees
  • Maintain project plans and tracking tools for site activation
  • Customize country-specific patient information and consent forms

📋 Requirements

  • Bachelor's degree in life sciences or related field
  • Experience as Regulatory or Start Up specialist in CRO/pharma
  • Proficiency in computerized information systems and spreadsheets
  • Fluency in English
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