Regulatory Affairs

Senior Vice President, Global Head of Regulatory Affairs

about

The Partner
We Worked With

Our partner is a preclinical-stage, publicly traded biopharmaceutical company that is shaping the future of heart disease treatment driven by a bold mission: to discover, develop and deliver curative therapies that address the underlying drivers of disease. Founded by leading cardiology researchers, they are developing therapies for rare genetic disorders as well as for more prevalent heart conditions through three platforms: Gene Therapy, Regeneration and Precision Medicine.

objectives

The Need
We Filled

As the first regulatory hire, they played a critical role in developing the regulatory roadmap, as well as establishing regulatory strategy for the organization. They implemented SOPs, policies, and procedures to build the regulatory function from the ground up. As an executive hire, they led programs targeting genetic mutations getting ready for IND.

key metrics

Proven, measurable
results

STAT. 1
66

days until hired candidate presented

STAT. 2
3

candidates presented

STAT. 3
141

days until search completed

Record of Success

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