Regulatory Affairs

Senior Director, Regulatory Operations

about

The Partner
We Worked With

Our partner is a gene therapy company focused on developing life-saving medicines for neuromuscular, CNS, cardiovascular, and metabolic diseases. Their pipeline includes therapeutics for conditions like heart failure, Huntington’s disease, and Parkinson’s disease, supported by their Pro10™ cell line manufacturing process and extensive capsid and promoter library.

objectives

The Need
We Filled

This critical hire led regulatory strategy and operations, overseeing the preparation, submission, and management of regulatory filings. They ensured global compliance, coordinated with regulatory agencies, and managed submission timelines. This individual collaborated with cross-functional teams to streamline processes, drive efficiencies, and ensure timely product approvals, while implementing best practices and supporting the company’s strategic goals.

key metrics

Proven, measurable
results

STAT. 1
21

days until hired candidate presented

STAT. 2
5

candidates presented

STAT. 3
47

days until search completed

Record of Success

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