🛠 Tech Stack

💼 About This Role

You'll lead regulatory submissions and site start-up activities for clinical trials across Mexico. You'll ensure timely site activation by managing Competent Authority and IRB/Ethics Committee approvals. This role offers remote flexibility within a growing clinical research organization.

🎯 What You'll Do

• Prepare and submit Clinical Trial Application forms and dossiers to Competent Authorities and Ethics Committees.
• Maintain project plans, trackers, and regulatory intelligence tools for site start-up activities.
• Partner with site CRAs to ensure alignment and secure site collaboration.
• Review and manage essential documents for site activation and IMP release.

📋 Requirements

• Bachelor's degree in life sciences or related field, or Registered Nurse (RN).
• 3.5+ years as a Regulatory or Site Start-Up specialist in CRO or pharma/biotech.
• English proficiency (professional level) both verbal and written.