Roberta Smithey is a seasoned life science regulatory, clinical and quality compliance specialist with a strong mix of large sponsor, small startup, and research site experience. She offers regulatory filing and quality compliance services to clients and also serves on the Board for Pearl IRB. Roberta has been the Director of Regulatory Affairs at a startup biotech where she was responsible for all aspects related to Regulatory global operations and submissions. She has 25 years experience related to the planning, implementation, and process of completing global regulatory submissions. She provides expertise on CTD and eCTD formats, risk management, and post submission activities.
Roberta has been directly involved in most major submissions made by Eli Lilly and Company during her tenure there. As a member of the original Lilly regulatory component, Roberta established the first centralized submission team. Her expertise in clinical trials also spans providing onsite clinical research coordinator site support, sponsor clinical project management, protocol development, CRF design, data capture and edits, as well as authoring integrated documents and labels for submissions. Therapeutic experience includes most major disease categories with special expertise in delivery devices, infectious disease, CNS, CV, diabetes, oncology, orthopedics, and osteoporosis