💼 About This Role

You'll lead regulatory strategy and submissions for innovative oncology therapies, ensuring compliance with FDA, ICH, and global standards. Your work will directly enable efficient drug development and approval processes in a fast-paced, science-driven environment.

🎯 What You'll Do

• Prepare and manage IND submissions and amendments in eCTD format
• Lead cross-functional teams to support global regulatory objectives
• Monitor regulatory changes and assess impact on development programs
• Support NDA filing activities and associated regulatory strategies

📋 Requirements

• Bachelor's degree in Regulatory Science or related field with 3+ years experience
• Hands-on experience with IND submissions and amendments
• Strong knowledge of eCTD submission standards
• Ability to interpret FDA, ICH, EMA, and PMDA regulations

✨ Nice to Have

• Master's degree in relevant field
• Experience in oncology drug development
• Experience with global regulatory submissions

🎁 Benefits & Perks

• 💰 Competitive base salary $168,064-$178,000 USD
• 🏥 Healthcare and wellness support
• 🏖️ Remote work flexibility across continental US
• 📈 Professional development opportunities

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

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