Jamie Gault has been promoted to global head of Regulatory Affairs and will oversee preparation of regulatory packages for agencies globally. Ms. Gault joined the company in 2012 and served in a senior quality assurance role. She has 25 years experience in regulatory roles both at sponsor and CRO organizations. Her regulatory experience spans drugs, biologics, cell and tissue-based products, combination products and medical devices, as well as the management of INDs, IDEs, NDAs, and 510(k)s regulatory submissions.
Also, Kathleen Zajd has been named vice president, Global Quality and Compliance. She previously served on Novella’s senior management team following the acquisition of Prologue Research International in 2010. Prior to co-founding Prologue, Ms. Zajd held leadership roles in clinical operations, regulatory and quality with experience spanning more than 25 years across both service organizations and sponsor companies (pharma and medical device). She has extensive knowledge of GCPs/GLPs, ICH requirements, international directives/laws that govern the conduct of global clinical trials, and is experienced with all aspects of the clinical trial process.
Novella Clinical president and chief executive officer Richard Staub, said, “We are fortunate to work with an extremely high caliber of professionals. I am confident we have the right people in the right positions to propel Novella into our next phase of growth.”