James Zoshak is currently an associate principal regulatory writer at Certara. He is an experienced and detail-oriented chemistry, manufacturing, and controls (CMC) regulatory project manager, writer, and editor, with more than 14 years of experience. In his role, he plans, organizes, writes, reviews, and edits CMC regulatory submissions and other relevant documentation in support of the registration of numerous small molecule, biopharmaceutical, and gene therapy products marketed across the globe. In addition to his other responsibilities, he worked on-site as the primary liaison to one of Synchrogenix’s largest clients for ten years.
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