🛠 Tech Stack

💼 About This Role

You'll lead CMC regulatory activities for radiopharmaceutical products at a fast-growing company. Your work will directly support global submissions from early to post-approval stages. This role offers hybrid/remote flexibility and equity incentives.

🎯 What You'll Do

• Author CMC regulatory dossiers (3.2.S and 3.2.P sections)
• Prepare eCTD Module 2.3 and 3 documents for submissions
• Assess manufacturing changes and conduct comparability studies
• Collaborate with cross-functional teams on CMC content

📋 Requirements

• 7+ years CMC experience in radiopharmaceutical or biopharmaceutical industry
• Advanced degree (M.Sc./Ph.D.) in Biological Sciences or related field
• Solid knowledge of ICH guidelines and FDA/EMA regulations
• Technical writing skills for Module 3 documentation

✨ Nice to Have

• Experience with Veeva regulatory system
• Knowledge of radiopharmaceutical manufacturing

🎁 Benefits & Perks

• 💰 Competitive salary
• 🏆 Annual performance-based bonuses
• 📈 Equity-based incentive program
• 🏖️ Generous vacation and paid wellness days
• 📚 Support for learning and development

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Technical Interview· 60 min