Regulatory Affairs

Director, Head of Regulatory Operations

about

The Partner
We Worked With

Our partner is a clinical-stage biotechnology company focused on delivering novel therapies for autoimmune diseases with the heaviest patient burdens. They are rapidly developing a pipeline of medicines targeted to the specific molecular dysregulations underlying severe autoimmune conditions, unlocking new treatment options for patients who are underserved by existing therapies.

objectives

The Need
We Filled

This critical hire was responsible for managing the regulatory operations infrastructure and overseeing the regulatory publishing and document management needs. They oversaw all regulatory operations activities for the programs including document archiving, submissions planning, publishing, QC, and submissions management.

key metrics

Proven, measurable
results

STAT. 1
51

days until hired candidate presented

STAT. 2
14

candidates presented

STAT. 3
79

days until search completed

Record of Success

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