🛠 Tech Stack

💼 About This Role

You'll assist the Regulatory submissions team in QC, coordination, and submission of documents within Europe. Your work ensures compliance with EU CTR and CTIS for ophthalmic clinical trials. This role offers the chance to impact global drug development at a leading ophthalmic CRO.

🎯 What You'll Do

• Perform quality control checks on clinical and regulatory documents
• Prepare and submit documents to regulatory authorities and ethics committees via CTIS
• Oversee country adaptation of study documents and ensure sponsor approval
• Maintain tracking logs and filing of regulatory documents

📋 Requirements

• Bachelor's degree in life science or related field
• 3 years of regulatory or clinical experience
• Experience with CTIS and EU CTR submissions
• Proficiency in Microsoft Office, especially Word

✨ Nice to Have

• Experience updating PIS/ICF templates
• Familiarity with ICH-GCP standards
• Multi-lingual communication skills

🎁 Benefits & Perks

• 🏖️ Remote work within Europe
• 💼 Full-time position with global impact
• 📚 Opportunities for professional growth in regulatory affairs
• 🤝 Collaborative team environment

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Phone Screen· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Technical/Regulatory Assessment· 60 min