🛠 Tech Stack

💼 About This Role

You'll support regulatory submissions to FDA and ex-US agencies for a clinical-stage biotech. You'll act as data steward of regulatory information in the RIM system, ensuring accuracy and compliance. This role offers growth in a fast-paced environment shaping company culture.

🎯 What You'll Do

• Maintain regulatory data in RIM system
• Create and archive regulatory submissions
• Coordinate submission planning with cross-functional teams
• Perform QC activities for eCTD submissions

📋 Requirements

• BS in related scientific discipline
• 2+ years in pharmaceutical/biotech industry
• Strong organizational and detail-oriented skills
• Proficiency in MS Office suite

✨ Nice to Have

• Regulatory affairs experience
• Experience with Veeva RIM and eCTD submissions
• SharePoint/Teams proficiency

🎁 Benefits & Perks

• 🏖️ Three weeks PTO plus two company-wide shutdowns
• 💰 Market competitive compensation and equity
• 🧑‍⚕️ Health, welfare, and retirement benefits
• 📈 Professional development resources
• 🤝 Regular in-person all-team meetings

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

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