Regulatory Affairs

Vice President, Regulatory CMC

about

The Partner
We Worked With

Our partner is making history with every clinical advancement and aspires to turn hope into cures by unraveling new possibilities for genetic medicine. Almost 40 years ago, their scientific co-founder was the first to demonstrate that adeno-associated virus (AAV) could be cloned for therapeutic purposes. This groundbreaking research propelled the most exciting field in medical research today and inspires their world-leading gene therapy platform that is bringing new therapeutics to market and resulting in new methods for lowering the cost of delivery.

objectives

The Need
We Filled

This critical hire contributed towards development, registration, life cycle support, as well as CMC regulatory strategy. They were a key interface between the Regulatory and the Technical Operations functions, to create and implement CMC regulatory strategies for CTA submission and marketing applications.

key metrics

Proven, measurable
results

STAT. 1
34

days until hired candidate presented

STAT. 2
6

candidates presented

STAT. 3
69

days until search completed

Record of Success

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