Jennifer Eck
MedImmune
Associate Director, Regulatory Affairs CMC
An experienced regulatory CMC professional. She received a BA in Chemistry Education from the University of Delaware and a MS in Regulatory Affairs from Temple University. She started her career as an analytical chemist at Sterling Winthrop and Sanofi. She then transitioned into technical dossier authoring of CMC quality sections for INDs, NDAs, and BLAs, leading submission preparation in combination with regulatory affairs. <br><br>
She wanted a greater challenge and moved into post approval regulatory affairs at Centocor (Janssen Biotech Inc.) for specified biotechnology products. There she developed regulatory strategy and content proposals for post-approval CMC supplements for the United States, Canada, and Europe as well as the Rest of the World. She assessed manufacturing changes globally as to filing categorization and required information necessary for submission and liaising with global health authorities.<br><br>
She transitioned to Astra Zeneca/MedImmune LLC where she currently is a Regulatory Affairs CMC product lead responsible for supporting global CMC clinical trial applications, marketing applications as well as post approval submissions. She also partners with biotechnology manufacturing facilities to provide regulatory and inspection support for both internal programs as well as clients/third parties and manufacturing partners for a variety of monoclonal antibody and therapeutic protein programs.
She wanted a greater challenge and moved into post approval regulatory affairs at Centocor (Janssen Biotech Inc.) for specified biotechnology products. There she developed regulatory strategy and content proposals for post-approval CMC supplements for the United States, Canada, and Europe as well as the Rest of the World. She assessed manufacturing changes globally as to filing categorization and required information necessary for submission and liaising with global health authorities.<br><br>
She transitioned to Astra Zeneca/MedImmune LLC where she currently is a Regulatory Affairs CMC product lead responsible for supporting global CMC clinical trial applications, marketing applications as well as post approval submissions. She also partners with biotechnology manufacturing facilities to provide regulatory and inspection support for both internal programs as well as clients/third parties and manufacturing partners for a variety of monoclonal antibody and therapeutic protein programs.