Oklahoma City, OK | Cullowhee, NC
Also known as: SixClanHero
We are a new Oklahoma City based Band, we have a heavy and light acoustic sound! We are releasing our debut CD in August 2011! Check us out! follow on twitter@SixClanHero and we'll follow back!
Also known as: LaurenHR
Lauren Richardson lives in Fort Mill, SC. She has also lived in Charlotte, NC. She went to school at the University Of Alaska Anchorage, Converse College and North Augusta Sr High School. She works at Certified Business Coach At Focalpoint Business Coaching as an Owner. Mysteries is her favorite movie.
Also known as: evan_r
I am a broadly-experienced regulatory affairs professional, specializing in eCTD submissions, FDA interactions, and project management. In the last five years, I have contributed to the approval of three marketing applications. I have compiled hundreds of regulatory submissions, including multiple eCTD INDs and marketing applications. I have acted as the U.S. Agent and Regulatory Contact for several sponsors, and I've participated in many FDA interactions, including Advisory Committee meetings, Application Orientation meetings, End of Phase meetings, Pre-IND meetings, and Type C meetings. As a project manager, my experience includes conducting a quality assurance investigation into abnormal laboratory results in an ongoing clinical trial managing the collection, review, and reporting of distribution data for a marketed product and leading the effort to collect rare, hyper-immune plasma for the manufacture of a plasma-derived orphan product. Specialties regulatory affairs, regulatory strategy, eCTD submissions, document formatting, project management, labeling, FDA, biologic products, combination products, Pre-IND, IND, NDA, BLA, ESG
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