Director of CMC Regulatory Affairs

Job Summary

A company is looking for a Director, CMC Regulatory Affairs.

Key Responsibilities

• Lead global CMC regulatory strategy for investigational and early commercial biological products
• Serve as a key strategic partner in cross-functional networks, advising various stakeholders
• Own submission content and ensure compliance with regulatory requirements to protect supply

Required Qualifications

• Degree in biological sciences, chemistry, pharmacy, engineering, or a related scientific discipline
• Extensive CMC regulatory experience in biopharmaceuticals
• Experience with development and manufacturing requirements
• Advanced degree (MSc or PhD) is preferred
• Experience leading CMC regulatory teams is a plus