Octagon's Management Team

NANCY SMERKANICH – VICE PRESIDENT, REGULATORY AFFAIRS CONSULTING

As Vice President of Regulatory Affairs Consulting, Ms. Smerkanich is responsible for advising sponsors on regulatory filing strategy and submission development. With over 28 years of experience, Nancy has participated in all regulatory aspects of drug development. She has prepared and maintained numerous IND/CTx applications and New Drug/Marketing Authorization Applications and their related submissions, most of which were formatted as eCTDs. She has also written Global Guidance Interpretations, Standard Operating Procedures and Guidance documents used by many of the leading pharmaceutical companies.

Ms. Smerkanich holds a Bachelor of Science Degree in Microbiology and a Bachelor of Arts in Russian from the University of Connecticut. She is a member of the TOPRA (The Organization for Professionals in Regulatory Affairs) and DIA (Drug Information Association) Electronic Regulatory Submissions SIAC and was the recipient of the DIA Outstanding Service Award for 2004. Ms. Smerkanich was also recognized by PharmaVoice as one of the industry’s Top 100 people in 2005.