🛠 Tech Stack

💼 About This Role

You'll lead global regulatory strategy and submission management for oncology drug development programs from IND/CTA through NDA/MAA. You will integrate strategic planning with hands-on execution, ensuring compliance with health authority requirements. This role offers the chance to shape regulatory pathways at an innovative early-stage company with experienced industry veterans.

🎯 What You'll Do

• Participate as regulatory representative for Clinical Study Team
• Support preparation and execution of regulatory submissions (IND/CTA, NDA/MAA, etc.)
• Provide regulatory guidance to senior members on various projects
• Maintain regulatory information system and ensure proper archiving

📋 Requirements

• 6-8 years of experience in Regulatory Affairs
• Bachelor or advanced degree in a scientific field
• Proven experience in preparation of quality dossiers in required formats
• Knowledge of e-CTD specifications for electronic submissions

✨ Nice to Have

• Master's degree
• Experience with preparing meeting packages
• Proficiency with docuBridge, Veeva Vault RIM

🎁 Benefits & Perks

• 🏥 Medical, dental, and vision insurance
• 💰 401(k) retirement savings plan
• 🏖️ Generous PTO with summer and winter shutdown

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Technical Interview· 60 min