🛠 Tech Stack

💼 About This Role

You'll lead CMC regulatory dossiers for radiopharmaceutical products, supporting global submissions from early to post-approval. Your work will directly enable the international roll-out of a prostate cancer imaging agent and advance a portfolio targeting unmet needs in oncology.

🎯 What You'll Do

• Author CMC regulatory dossiers (Module 3) for global submissions
• Manage change assessments for manufacturing changes and site transfers
• Identify CMC regulatory risks and propose mitigation plans
• Collaborate cross-functionally with QA, CMC, and preclinical teams

📋 Requirements

• 7+ years in CMC regulatory in radiopharma or biopharma industry
• Advanced degree in Biological Sciences or Engineering preferred
• Solid knowledge of ICH guidelines and FDA/EMA regulations
• Expertise in authoring Module 3 technical dossiers

✨ Nice to Have

• Experience with eCTD submissions
• Knowledge of Veeva regulatory systems
• Prior work with radiopharmaceuticals

🎁 Benefits & Perks

• 💰 Competitive salaries and annual performance bonuses
• 📈 Equity-based incentive program
• 🏖️ Generous vacation and paid wellness days
• 📚 Learning and development support
• 🌍 Hybrid and remote work options

📨 Hiring Process

Estimated timeline: 3-4 weeks · AI estimate

1. 1Recruiter call· 30 min
2. 2Hiring manager interview· 45 min
3. 3Technical interview· 60 min