Dianne Harris
About Dianne Harris
Dianne Harris is a Manager of Regulatory Operations at Roivant Sciences, with extensive experience in clinical trials and regulatory affairs. She has held various positions in notable companies such as Chiltern, Parexel, and PPD, contributing to her expertise in the field since the early 2000s.
Current Role at Roivant Sciences
Dianne Harris serves as the Manager of Regulatory Operations at Roivant Sciences, a position she has held since 2018. In this role, she is responsible for overseeing regulatory processes and ensuring compliance with industry standards. Her work contributes to the efficient management of regulatory submissions and communications, which are critical for the advancement of pharmaceutical products.
Previous Experience in Clinical Trials
Before joining Roivant Sciences, Dianne Harris accumulated extensive experience in clinical trials. She worked at Chiltern in various roles, including Senior Clinical Trials Assistant, Manager of Clinical Trials Administration, and Manager of Clinical Operations from 2008 to 2017. Additionally, she held positions at Parexel as a Senior Study Startup Analyst and Lead, and at Quintiles as a Site Start-up Specialist and Lead, where she developed her expertise in clinical operations and regulatory compliance.
Educational Background
Dianne Harris studied at Kaplan University, where she achieved an Associate's degree in Applied Science. She also pursued studies in Management, which provided her with a foundational understanding of organizational practices and leadership skills relevant to her career in regulatory operations.
Training and Professional Development
Dianne Harris has participated in various training programs to enhance her skills in regulatory compliance and clinical research. She completed PPD File Audit Training, which focused on regulatory compliance practices. Additionally, she underwent PPD CRA Foundation Training, strengthening her knowledge and abilities in clinical research and regulatory affairs.
Engagement in Regulatory Affairs
Dianne Harris actively engages with the North Carolina Regulatory Affairs Forum, where she contributes to discussions on regulatory practices. This involvement reflects her commitment to staying informed about industry trends and best practices in regulatory operations.