Lauren Neighbours is the Head of Regulatory Affairs, North America at PSI where she leads regulatory strategy for PSI in the US and Canada. Lauren has over 10 years of scientific research experience within industry, government, and academic settings.
She has led multidisciplinary product development programs from the pre-IND stage through marketing, partnering with early-, mid-, and late-stage companies to develop and refine strategic development plans, design and execute clinical studies, lead regulatory submissions, and provide support for regulatory authority meetings and other consulting needs.
Lauren also has experience coordinating and overseeing the strategy and operations of full-service Phase 1-4 clinical studies spanning many therapeutic areas and product types. Lauren has authored a variety of clinical and regulatory documents, and has contributed as an author to multiple IND/CTA and marketing application dossiers.
Lauren holds a PhD in Microbiology and Immunology and obtained her Regulatory Affairs Certification from the Regulatory Affairs Professional Society. She maintains professional membership with several regulatory and pharmaceutical societies and serves as the Vice President of Programs for the North Carolina Regulatory Affairs Forum.