Roberta Smithey

Roberta joined Apexian in December of 2014. Her experience in regulatory affairs, clinical research and product development, ranging from large multinationals to start-ups, allows her to bring tremendous focus and perspective to the team.

For the past five years, Roberta has served on the Pearl Pathways IRB and consulted with several small companies to develop their submission strategy, document management systems and deliver global electronic submissions. Previous to that, she was Director of Regulatory Affairs for BioCritica and Targanta Therapeutics.

Roberta spent the majority of her career at Eli Lilly and Company in the planning, implementation and completion of numerous global regulatory submissions. She provides expertise on CTD and eCTD formats, risk management and post submission activities. She was directly involved in most major submissions made by Eli Lilly and Company during her career, including leading the process for Lilly’s first centralized submission team. Prior to her work in regulatory affairs, Ms. Smithey held multiple roles in the Medical division of the company where she worked on protocol development, CRF design, data management, completion of study reports and preparing integrated documents and labels for submissions.

Roberta received a B.S. degree in chemistry from the University of Indianapolis.