Senior Director, Global Regulatory CMC

Job Summary

A company is looking for a Senior Director, Global Regulatory CMC- Drug- Device Combination Products.

Key Responsibilities

• Define and own the global regulatory CMC strategy for drug-device combination products
• Lead global regulatory strategy development and execution across various stages of product lifecycle
• Act as the senior regulatory representative with global Health Authorities for device and combination product portfolios

Required Qualifications

• Bachelor's degree and 15+ years of experience in Medical Device and Combination Product Regulatory Affairs
• At least 10 years of experience leading global regulatory organizations in pharmaceutical or biotechnology environments
• Demonstrated regulatory leadership across Class II devices and In-Vitro Diagnostics
• Extensive experience in global Health Authority engagements and negotiations
• Expert knowledge of regulatory expectations for device and combination product licensure