💼 About This Role

You'll manage regulatory submissions for a late-stage oncology company developing novel RAS inhibitors. Your work directly supports NDA filing activities and global health authority interactions, accelerating therapies for patients with RAS-addicted cancers.

🎯 What You'll Do

• Manage planning, preparation, and submission of regulatory documents to global health authorities.
• Assist and track detailed timelines for regulatory activities and submissions.
• Perform regulatory research to assess implications and inform drug development strategy.
• Support NDA filing activities and develop regulatory processes for filing.

📋 Requirements

• Bachelor's degree in Regulatory Science or related Life/Health Science field.
• Three years of experience in Regulatory Affairs at a drug or biologics company.
• Experience managing IND applications and amendments.
• Experience with eCTD format submissions and FDA/ICH/EMA/PMDA regulations.

✨ Nice to Have

• Master's degree in Regulatory Science or related field.
• Oncology drug development experience.

🎁 Benefits & Perks

• 💰 Base pay salary range $168,064 - $178,000 USD
• 🏦 Robust equity awards
• 🏥 Strong benefits (medical, dental, vision)
• 📚 Significant learning and development opportunities

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter screen· 30 min
2. 2Hiring manager interview· 45 min
3. 3Technical/behavioral interview· 60 min