Mckenzie Orchowski
Founder and Principal Consultant
Mckenzie is a seasoned regulatory operations professional with over 12 years of experience specializing in eCTD electronic publishing. She is adept at compiling submissions for clinical trial authorizations and marketing applications to the FDA for drugs, biologics, and medical devices.
Her exceptional communication skills, combined with her high attention to detail, consistently ensure top-tier client support and successful project outcomes.
She holds a master’s degree in Biotechnology Management from Southern Illinois University Edwardsville and a bachelor’s degree in Molecular Bioscience and Biotechnology from Arizona State University.
Previously, Mckenzie served as the Associate Director of Regulatory Operations at Biologics Consulting, where she played a key role in scheduling client submissions, delegating publishing tasks, and preparing/submitting eCTD sequences for INDs, BLAs, NDAs, ANDAs, and Master Files (using IQVIA RIM Smart, Rosetta Phoenix, and DXC ToolBox). She also assisted with Word document formatting (using Accenture StartingPoint templates). In addition, Mckenzie was responsible for training new and existing employees on publishing processes, ICH/FDA guidance, and emerging data standards.
At Translational Drug Development (TD2), an oncology CRO, Mckenzie served as Regulatory Operations Manager. She acted as a project manager, developing detailed Gnatt charts (using Microsoft Project), and independently published all client eCTD submissions (using Lorenz DocuBridge).
Mckenzie played an instrumental role at Arivis AG (formerly Mission3, Inc.), enhancing the company’s home-grown eCTD tool, FastCrossing, by working closely with software development teams and drafting user requirements for the eventual deployment of Clireo, with planned eCTD v4.0 functionality.
Early in her career, Mckenzie was a Senior Publishing Specialist at Medicis Pharmaceutical Corporation, where she coordinated the outsourcing of a major 505(b)(1) NDA to Quintiles. Mckenzie published initial INDs and 505(b)(2) NDAs in-house (using eCTDXPress), while overseeing lifecycle maintenance submissions for over 27 products. Her responsibilities also included preparing eCopies for CDRH to accompany paper submissions for medical devices under IDEs and PMAs, submitting hundreds of promotional pieces to OPDP, and archiving all FDA correspondence in 21 CFR Part 11-compliant document management systems (such as Documentum and SharePoint).
Having worked on all sides of the pharmaceutical industry—at a sponsor, CRO, eCTD software vendor, and consulting firm—Mckenzie has developed a strong ability to manage complex, multi-disciplinary regulatory submissions with ease.