Brian M. Walton, Ph.D. Email & Phone Number

Atlanta, Georgia, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Greater Chicago Area

Provide regulatory support and guidance to cross-functional teams on labeling and labeling updates for drug device combination products pending FDA approval and products currently marketed within the U.S. • Serve as regulatory labeling lead for the sterile injectables combination products group.• Leverage deep scientific and labeling expertise to serve as the regulatory labeling subject matter expert for vasodilators (heart and lung), opioids, opioid antagonists, anesthetics, and sedatives.• Perform extensive market research and provide input on labeling strategy to medical and commercial teams.• Deliver presentations to cross-functional teams on recommendations for labeling and updates based on FDA guidance.• Monitor projects to ensure labeling updates are completed on time and in accordance to new FDA guidance.• Collaborate with cross-functional teams from Quality, R&D, Safety, Clinical, Medical, and Commercial to ensure compliance with regulatory guidelines.• Coordinate, author, and review product specification documents intended to win the market in a first- to-file future device-drug regulatory submission. • Conduct regulatory assessments and present findings to support changes to product design, labeling, packaging, or manufacturing processes to maintain compliance with the FDA for on market products.

Doctor Of Philosophy - Phd, Biomedical Engineering

Activities and Societies: Alfred P. Sloan Foundation Graduate Student Fellow, Texas A&M University Diversity FellowDesigned, initiated.

Certificate In Business Management For Engineering, 1St Place Winner Capstone Project

Capstone Title: Endotracheal Tube Cuff Leak Detection System

Bs, Physics

Activities and Societies: National Society of Black Physicists, Presidential Ambassadors