🛠 Tech Stack

💼 About This Role

You'll translate global regulatory strategies into actionable execution plans for oncology drug programs. You'll guide cross-functional teams to support marketing applications across the portfolio. This role offers the chance to impact RAS-addicted cancer therapies at a late-stage clinical company.

🎯 What You'll Do

• Manage regulatory submissions from initiation through submission
• Develop and track submission timelines for INDs, NDAs, MAAs
• Partner with Regulatory Science Leads to advance global strategies
• Facilitate Global Regulatory Teams and meetings
• Coordinate filing activities across cross-functional Filing Teams

📋 Requirements

• Bachelor's degree in life sciences or related discipline
• 15+ years pharma/biotech experience
• 8-10 years regulatory project management experience
• Hands-on U.S. drug marketing application experience

✨ Nice to Have

• Experience with global regulatory filings (Japan, Canada, EU/UK)
• Oncology drug development experience
• Experience with complex oncology clinical trial designs

🎁 Benefits & Perks

• 🏖️ Hybrid work model
• 💰 Competitive base pay with range $220,000-$280,000
• 🏥 Comprehensive benefits (not specified)

📨 Hiring Process

Estimated timeline: 3-5 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 60 min
3. 3Panel Interview· 90 min

🚩 Heads Up

• 15+ years experience requirement may be excessive for Director level
• Hybrid requirement could limit remote flexibility