Job Summary

A biotechnology company has an open position for a Remote US Regulatory Lead.

Core Responsibilities of this position include:

• Ensuring communications from the FDA are properly communicated to the business
• Partnering with US Commercial and Ad Promo Team
• Being responsible for IND and BLA submissions to FDA in partnership with Regulatory Operations

Qualifications Include:

• At least 5 years experience working in regulatory affairs
• 6+ years' experience in the pharmaceutical industry within R&D, Regulatory or a related function
• Experience working with the FDA
• Great leadership skills with high emotional intelligence
• Must be a great team player with strong verbal and written communication skills