Kehlen Flannery Rossi
About Kehlen Flannery Rossi
Kehlen Flannery Rossi is the Manager of Regulatory Operations at Alkermes in Waltham, Massachusetts, with over 15 years of experience in the regulated industry, including expertise in GxP requirements and regulatory filings.
Current Position at Alkermes
Kehlen Flannery Rossi holds the position of Manager, Regulatory Operations at Alkermes in Waltham, Massachusetts. She is responsible for overseeing the regulatory operations, ensuring compliance with FDA and international regulatory requirements, and managing document reviews, formatting, publishing, and compilation of regulatory filings. Her role is critical in supporting the regulatory strategy and submission processes within the organization.
Previous Experience at Karyopharm Therapeutics Inc.
From 2016 to 2018, Kehlen Flannery Rossi worked at Karyopharm Therapeutics Inc. as Principal Associate, Regulatory Informatics, Operations and Technology. During her tenure, she focused on regulatory informatics, contributing to the operational and technological aspects of regulatory affairs. Her role encompassed the management of regulatory submissions and ensuring adherence to compliance standards in the Greater Boston Area.
Roles at AstraZeneca
Kehlen Flannery Rossi served at AstraZeneca from 2011 to 2015, initially as a Discovery Documentation Coordinator and later as a Regulatory Operations Specialist. In her capacity as a Documentation Coordinator, she was involved in managing discovery documentation processes. As a Regulatory Operations Specialist, her responsibilities included regulatory submissions, document quality checks, and compliance with regulatory standards in Waltham, MA.
Early Career at RXi Pharmaceuticals and Other Organizations
Between 2005 and 2011, Kehlen Flannery Rossi gained substantial experience at RXi Pharmaceuticals Corp as Senior Research Associate I. Prior to that, she worked at Toxikon Corporation as a Pharmacology Technician II and at Charles River Laboratories in various roles including Research Assistant and Technician. In these roles, she conducted in vivo studies, performed quality checks on laboratory data, and adhered to GLP and non-GLP standards.
Education and GxP Expertise
Kehlen Flannery Rossi earned a BS in Criminal Justice from Salem State College, where she studied from 1999 to 2004. With over 15 years in the regulated industry, she has in-depth knowledge of GxP requirements within FDA regulated environments as well as international standards like EMA and Health Canada. Her expertise includes quality checks, standard operating procedures (SOPs), and extensive experience with regulatory filings such as INDs, NDAs, and MAAs.