🛠 Tech Stack

💼 About This Role

You'll provide regulatory guidance and coordinate submissions for clinical trials. Your work ensures timely, compliant regulatory approvals. You'll collaborate with global teams on CTA/IND applications and scientific advice procedures.

🎯 What You'll Do

• Compile and review regulatory submissions to authorities
• Provide strategic regulatory input to project teams
• Maintain project plans and trackers
• Oversee Regulatory Affairs Specialists

📋 Requirements

• Bachelor's degree in scientific or healthcare discipline
• 5+ years regulatory affairs experience
• Knowledge of drug development process inclusive of regulatory milestones
• Expertise in EU or US regulatory activities