Related skills
regulatory affairs clinical trials translation documentation management ich-gcp📋 Description
- Ensure timely, high-quality site activation readiness for assigned sites.
- Prepare Clinical Trial Applications and submission dossiers for CA/EC (initial and amendments).
- Ensure local regulatory compliance and adherence to ICH-GCP.
- Interface with CA/EC and respond to inquiries.
- Provide CA/EC submission updates to startup/regulatory leads and project team.
- Maintain project plans, trackers, and regulatory intelligence tools for leadership.
🎯 Requirements
- Experience as Regulatory/Start Up specialist in CRO or pharma.
- Experience customizing ICFs for Germany.
- Bachelor’s degree in life sciences or RN.
- Strong communication and organizational skills.
- Experience with computerized systems, spreadsheets, word processing, and email.
- Fluency in English and the local language; ability to prioritize deadlines.
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