Vice President of Research and Development, Regulatory and Government Affairs
Kristie Stephens joined Lannett Company in 1999 and was appointed vice president of regulatory affairs in 2016. Under her leadership, the regulatory affairs department has been instrumental in obtaining faster ANDA (Abbreviated New Drug Application) approvals and implementing internal electronic systems to fully comply with FDA submission requirements. The department services many different internal and external stakeholders with comprehensive, integrated systems and solutions and recently filed Lannett’s first NDA (New Drug Application) with full clinical studies.
“Lannett has a long history of achieving regulatory approvals and maintaining regulatory compliance. We are focused on submitting high quality applications to ensure patient access to safe, reliable medications as quickly as possible. We remain at the forefront of the organization for monitoring new and updated regulatory requirements and trends that will have an impact on our business.”
Kristie earned her Bachelor of Science degree in biology at Millersville University of Pennsylvania and earned her Master of Science degree in quality assurance/regulatory affairs at Temple University.