🛠 Tech Stack

💼 About This Role

You'll lead global regulatory CMC strategies for investigational vaccines at a clinical-stage biotech. Your work will directly impact BLA submissions and Health Authority interactions for innovative bacterial vaccines. This role offers a unique blend of strategic and hands-on responsibilities in a mission-driven environment.

🎯 What You'll Do

• Lead global regulatory CMC submissions and agency interactions
• Provide CMC regulatory guidance to cross-functional teams
• Manage regulatory assessment for change controls and deviations
• Stay current on evolving regulatory requirements and apply them

📋 Requirements

• Bachelor's degree in Biology, Chemistry, or related scientific field
• 10+ years experience in vaccine or biotech industry
• Experience preparing BLA CMC sections
• Knowledge of FDA, EMA, and ICH guidelines

✨ Nice to Have

• Post-approval supplement/variation experience
• IND/IMPD experience
• Prior development or manufacturing experience

🎁 Benefits & Perks

• 💰 Competitive salary
• 🏖️ Comprehensive benefits
• 📊 Equity component

📨 Hiring Process

Estimated timeline: 4-6 weeks · AI estimate

1. 1Application Review· 1 week
2. 2Phone Screen· 30 min
3. 3Technical Interview· 45 min
4. 4On-site/Final Interview· Half day
5. 5Offer· 1 week