💼 About This Role

You'll serve as a thought leader on regulatory affairs, defining global regulatory strategy for clinical programs. You will lead regulatory interactions with authorities and ensure timely submissions of key documents. This role offers the chance to work on innovative therapies for neuromuscular and cardiometabolic diseases.

🎯 What You'll Do

• Define global regulatory strategy and plan for assigned programs.
• Lead regulatory interactions with authorities and build trusted relationships.
• Ensure timely submission of key regulatory documents.
• Identify regulatory risks and develop solutions with stakeholders.

📋 Requirements

• 7+ years of Regulatory Affairs experience in biopharma.
• Deep understanding of EU regulatory requirements.
• Experience leading successful engagement with EMA.
• Biologics experience, particularly monoclonal antibodies.

✨ Nice to Have

• Experience with rare diseases.
• People management skills.