CMC dossier requirements:
FDA vs EU

Head of CMC, CCM RA Office NBE Dr. Christina Juli studied pharmacy at the University of Wuerzburg, Germany. After her PhD thesis in the fields of pharmaceutical chemistry, in 2012, she joined ratiopharm GmbH in Ulm, Germany and started her professional career as Senior Manager in the department of EU Regulatory Affairs Generic Maintenance. From 2018 to 2025, she was working at the manufacturing site for biopharmaceuticals in Biberach, Germany as Head of CMC Management CMB where she focused on the CMC development for biologics for the contract manufacturing business of Boehringer Ingelheim. In her current role as Head of CMC RA Office NBE, she focuses on the CMC development for biologics and is responsible for CMC regulatory topics of development projects, products, and strategic regulatory projects. Beyond that she is an active participant of several industry groups such as the BioPhorum Operations Group (Post Approval Strategy and Regulatory Governance working groups) or EFPIA.

Global Head of CMC Management Biopharma Dr. Beatrix Metzner studied chemistry at the University of Regensburg and Freiburg, Germany, specializing in biochemistry. Her professional career began at MediGene AG. In 2005, she joined Merck KGaA, where she worked as Director Global Regulatory Oncology until November 2013. At Boehringer Ingelheim, she held various management positions. Since January 2023 she acts as Global Head of CMC Management Biopharma. Dr Beatrix Metzner is a highly accomplished professional with more than 20 years experience in the CMC regulatory field of new biological entities (NBEs) and biosimilars.

Consultant for Drug Development; Dr. Tobias Zahn studied biochemistry at the University of Freiburg, Witten/Herdecke University, and the University of Colorado Health Sciences Center. Following a brief post-doc at the Max Planck Institute for Molecular Cell Biology in Dresden he joined 2005 the Berlin office of The Boston Consulting Group where he was consulting primarily in projects for big pharma, biotech and medtech companies. 2009 he moved to Birken AG (since 2016 an Amryt Pharma company), then a development-stage pharmaceutical company, where he led the clinical development and European approval (2016) of the lead asset, Episalvan. Since 2017 Dr. Zahn works as independent consultant at 3R Pharma Consulting GmbH. He advises clients on pharmaceutical product development and assists in regulatory proceedings such as orphan designations, scientific advice procedures, IMPD and CTD writing.
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