Regulatory Affairs

Vice President, Regulatory CMC

about

The Partner
We Worked With

Our partner is dedicated to developing treatments for allergic and inflammatory diseases, focusing on targeting specific immune pathways. Their goal is to address unmet medical needs and improve patient outcomes through innovative therapies that reduce inflammation and enhance disease control.

objectives

The Need
We Filled

This executive hire was responsible for successful completion of pre-BLA meetings and the company's module 3. They led teams with regulatory CMC responsibility for support of development, registration and life cycle support, and CMC regulatory strategy for the United States and EU. They were the key interface between Regulatory and the Technical Operations functions while partnering with regulatory support functions.

key metrics

Proven, measurable
results

STAT. 1
28

days until hired candidate presented

STAT. 2
4

candidates presented

STAT. 3
62

days until search completed

Record of Success

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