Josh Wooten has more than 3 years of experience in regulatory affairs, project management, and medical writing in the pharmaceutical industry. He has experience in regulatory strategy and also in the management of regulatory submissions to global health authorities including initial INDs/CTAs, informational amendments, meeting packages, and responses to information requests. He has also authored and managed the preparation of a variety of regulatory documents including EMA and FDA meeting packages, clinical and nonclinical study reports, orphan drug designation requests, and CTD modules.
Before joining Halloran, Josh worked at Parexel where he served as a full-time member of a global regulatory affairs team for a major pharmaceutical company. He has also worked at Nuventra where he served as a medical writer, project manager, and regulatory consultant.
University of North Carolina at Chapel Hill, PhD, Genetics & Molecular Biology
University of North Carolina at Chapel Hill, Bachelor of Science, Biology