🛠 Tech Stack

💼 About This Role

You'll lead regulatory submissions for a clinical-stage biotech advancing novel biologics. Your work directly supports FDA and ex-US filings that bring therapies to patients with inflammatory diseases. This high-visibility role offers cross-functional leadership in a fast-paced, well-funded Nasdaq company.

🎯 What You'll Do

• Lead preparation of INDs, CTAs, NDAs, and BLAs for FDA and ex-US agencies.
• Serve as primary interface with regulatory publishing for compliant electronic submissions.
• Coordinate cross-functional authorship and data collection for regulatory documents.
• Maintain regulatory submissions and correspondences in Veeva RIM system.

📋 Requirements

• 5+ years regulatory experience in biopharmaceutical drug development.
• Experience interacting with FDA and EMA.
• Proficiency in Veeva RIM and eCTD submissions.
• BS/MS/PhD in regulatory affairs or related scientific discipline.

✨ Nice to Have

• Regulatory Affairs Certification (RAC) credential.
• Experience with Microsoft Office SharePoint/Teams.
• Project management skills in a cross-functional environment.

🎁 Benefits & Perks

• 💰 Performance bonus and equity grant opportunities.
• 🏖️ Three weeks PTO plus two company-wide shutdowns.
• 🏥 Health, welfare, and retirement benefits.
• ✈️ Travel for All Hands meetings (up to 10%).

📨 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