At Spark Therapeutics, we are working to transform the lives of patients with a single dose. Our founding team includes pioneers in the field of gene therapy who have dedicated their careers to curing serious, debilitating genetic diseases. For the...
Hurley Consulting Associates
Familiarity with FDA and ICH guidelines, including knowledge of regulatory requirements specific to electronic submissions and differences and similarities across regions.
Experience with IND preparation and IND Amendments.
Experience with NDA...