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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