Yelena Vaydman

Yelena Vaydman

Regulatory Project Manager

Yelena Vaydman joined Biologics Consulting in April 2015. She provides regulatory support and project management for a variety of regulatory applications. Yelena has experience with original applications as well as application maintenance (amendments and supplements). She has worked with preparing, submitting and maintaining both paper and electronic submissions, as well as converting paper document submissions to electronic format. She serves as a US Agent representative and regularly liaises with FDA.


Education

MS, Regulatory Affairs for Drugs, Biologics, and Medical Devices, Northeastern University (2016)

BS, Biology, University of Massachusetts at Amherst, Amherst, MA (2009)

Minor in Music Performance (Piano), University of Massachusetts at Amherst, Amherst, MA (2009)

Member of the Commonwealth College, University of Massachusetts at Amherst, Amherst, MA (2009)