Bradford Bondor Email & Phone Number

Princeton, Nj, Us

Florham Park, Nj

Princeton, Nj

As a regulatory affairs associate, I act as a liaison between my company and the FDA. I am primarily responsible for ensuring the accuracy, completeness, and timely filing of applications, amendments, and supplements which describe the chemistry, manufacturing, and controls used in developing our generic products. I am significantly involved in the process of creating specifications and standard test procedures used at our plant. I also perform managerial functions; a self-updating spreadsheet with conditional formatting I created in Excel allows me to track my department's generic drug annual reports at a glance. I am used to working under a Consent Decree, and about six months ago I took on a responsibility formerly held by a Senior Manager: preparing and sending weekly letters to FDA's Office of Compliance. I am currently improving my skill at Visual Basic for Applications, which allows me to automate the more repetitive aspects of my job. I am also delving into Hatch-Waxman, including the mechanics of Para IV certification and the contents of patent notices. The synergy with my former experience as a patent attorney is tremendous. I love this field, which combines so many of my skills, and I look forward to advancing to a point where I can lead a team as well.

Alpha, Nj

With my two partners, I operated a martial arts school. I hold a fourth-degree black belt in Isshin Ryu karate.

Flemington, Nj

Doctor Of Law (J.D.), Intellectual Property Law

Activities and Societies: Managing Editor -- IDEA: The Intellectual Property Law Review, Articles Editor -- IDEA: The Intellectual.

Bachelor'S Degree, Chemistry

Activities and Societies: Concert Band, Jazz Band, Alpha Psi Chi