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Rachel Capone, MSHS

Regulatory Affairs Manager

Rachel Capone, Regulatory Affairs Manager at Syner-G BioPharma Group since October2021 comes with 9+ years’ experience in the pharmaceutical industry. Rachel is an experienced Regulatory Affairs professional in the pharmaceutical industry, skilled in global regulatory strategy, document drafting and strong program and project management.

Rachel spent most of her career on the Sponsor side of drug development with a focus on global regulatory strategy, R&D, early phase development and post approval projects. Rachel has been involved in receiving FDA approval for 2 major NDA submissions for products focused to treat substance use disorders and serious mental illnesses. Rachel also has experience preparing and reviewing regulatory documents including INDs, NDAs, annual reports, DSURs, PSMFs, orphan drug designation, fast track/breakthrough designations, protocols, and labeling.

Rachel also has experience with preparing strategies and meeting materials to facilitate discussions with FDA and has attended multiple FDA meetings including Type B, Type C and Advisory Committee Meetings.
Rachel’s work experience includes Impact Pharmaceutical Services, Indivior and PPD.

Rachel received a Master of Science in Health Sciences (MSHS) focused on Regulatory Affairs from The George Washington University School of Medicine and Health Sciences in 2019.

Rachel Capone, MSHS's Recent Articles

Conducting Clinical Trials in Australia

05 Apr 2024 | Nate DiTommaso, Rachel Capone, Renee Boerner Have you ever wondered why some companies choose to do their first in human clinical trials in Australia? Are there any real advantages or are people just looking for an…

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