Regulatory Affairs

Vice President, Regulatory CMC

about

The Partner
We Worked With

Our partner is a leader in the fields of mast cell and eosinophil biology and is focused on the central role these immune cells play in the pathogenesis of acute and chronic inflammatory conditions. The company’s lead drug candidate is an investigational therapeutic antibody that targets Siglec-8, which offers the potential to treat a broad range of serious, complex inflammatory diseases.

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
80

days until search completed

Record of Success

Related case studies