Stephen F. Amato, PhD, MBA, RAC

Managing Director, East Coast Operations

Stephen Amato, PhD, MBA, RAC, is Managing Director, East Coast Operations for Cardinal Health Regulatory Sciences.

Role responsibilities

Dr. Amato is responsible for managerial and operational oversight of the East Coast business segment, including development of strategic business initiatives and management of Cambridge office associates. He is responsible for the growth of East Coast business and interacts directly with clients and global regulatory health authorities, including participating in and facilitating discussions. 

Professional experience

Dr. Amato has more than 25 years of experience in product commercialization in the pharmaceutical, biotechnology and medical device industries. He currently serves as an Associate Professor of Graduate Global Regulatory Affairs at Northeastern University. Prior to Cardinal Health, he founded and served as the Managing Director for tJun17 Life Sciences, an organization that facilitates global commercialization and market access for early stage medical technologies. Prior to founding tJun17 Life Sciences, Dr. Amato was the Executive Director of Marketing at Anika Therapeutics where he managed all aspects of the company's product portfolio including market segmentation, targeting, positioning, pricing and promotional strategies.
From 2000 to 2007, Dr. Amato was the Group Director of Knee Repair at Smith & Nephew Endoscopy where he managed a $140 million orthopedic product portfolio. Prior to this experience, he worked for Visible Genetics, where he was responsible for developing and launching genomic molecular diagnostics products used for subtyping Human Papilloma Virus (HPV) and other infectious disease agents. He has also worked with Critical Therapeutics on the development and commercialization of treatments for gram negative sepsis. 

Therapeutic experience

Dr. Amato’s therapeutic areas of expertise include orthopedics, biomaterials, women's health, infectious disease and oncology.

Professional affiliations and awards

Dr. Amato received a United States and European Union Regulatory Affairs Certification (RAC) and is an industry consultant for the Regulatory Affairs Professionals Society (RAPS).

Education

Dr. Amato received a doctorate in molecular and cellular biology and a master’s degree in business administration from Boston College. He received a bachelor’s degree in biochemical sciences from Harvard University.

Areas of Expertise


Regulatory affairs

Product commercialization

Regulatory submissions

Medical devices

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