💼 About This Role

You'll lead global regulatory strategies for assigned products, ensuring life-cycle management and submission execution. You'll drive high-quality deliverables across US, EU, and other markets.

🎯 What You'll Do

• Ensure maintenance of global registrations for assigned products
• Lead submission strategy development and timeline definition
• Manage regulatory agency communications and responses
• Coordinate SMEs for health authority request responses

📋 Requirements

• 5+ years in regulatory affairs and major health authority frameworks
• Experience as a Regulatory Affairs lead across two or more major regions
• Experience with both small molecules and biologics
• Thorough understanding of drug development process and regulatory requirements

✨ Nice to Have

• Experience with pre- and post-approval lifecycle management
• Strong business acumen and decision-making skills
• Excellent written and verbal communication skills

🎁 Benefits & Perks

• 🏖️ Remote work
• 🏆 BioSpace Best Places to Work 2026
• 🌱 Career growth and development opportunities
• 💰 Financial rewards
• 🎯 Life-enhancing career impact

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

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