Manager, Regulatory Operations
Stephanie began her pharmaceutical regulatory career in 2001 with Pfizer as a Document Specialist within the Global Regulatory Group, primarily responsible for the formatting of pre-clinical documents and ensuring their submission readiness.
While at Pfizer, Stephanie moved into the Regulatory Chemistry Manufacturing and Controls (CMC) Group where she spent five years as a Submission Specialist; managing CMC regulatory submission documentation, including formatting, publishing and electronic document management for inclusion in INDs, CTDs, NDAs, MAAs, e-INDs and e-CTDs. She was a member of the Pfizer eIND implementation team and managed several electronic submissions to the EMEA and FDA.
From 2008 to 2013 Stephanie was employed in the medical device industry as a Regulatory Analyst for Centurion Medical Products Corporation, a custom convenience kit manufacturer. There she was responsible for ensuring compliance to all applicable FDA regulations as well as documenting and coordinating software validation activities and
completing label review for all products.
Stephanie has extensive experience with Microsoft Word and publishing tools ISIToolBox® and Adobe Acrobat.
Stephanie received a Bachelor of Science degree from Eastern Michigan University.