💼 About This Role

You'll develop and execute regulatory strategies for xenotransplantation programs at a clinical-stage biotech. Your core impact is managing complex FDA interactions across CVM and CBER to secure approval for engineered organs. This role offers a chance to navigate uncharted regulatory territory and drive life-saving organ transplant solutions.

🎯 What You'll Do

• Create regulatory strategies for transplant organ programs
• Manage FDA interactions and submission preparation
• Oversee CROs and consultants supporting regulatory activities
• Lead definition and tracking of regulatory milestones

📋 Requirements

• Bachelor's degree with 7+ years in Regulatory Affairs
• Experience with IND/INAD/NADA/BLA submissions
• Knowledge of GxP and manufacturing requirements
• Proven track record in FDA negotiations and presentations

✨ Nice to Have

• Advanced degree preferred
• Experience with xenotransplantation or gene therapy

🎁 Benefits & Perks

• 💰 Competitive base pay $161,600 - $242,400
• 🏥 Comprehensive benefits including health insurance
• 🚀 Growth opportunities at a clinical-stage biotech