Brian Kersten Email & Phone Number

San Mateo, Ca, Us

Us

Provide strategic Regulatory/Quality/Analytical Sciences management and act as a liaison for all Regulatory Affairs, Quality Assurance, Drug Safety and Analytical Sciences activities for internal management and global regulatory agencies for a small biotech company. Provide management oversight for all regulatory submissions as well as Quality Assurance, Drug Safety and Analytical Sciences activities during all phases of drug development. Development activities included Quality oversight of Clinical Development during the conduct of Phase 2 and Phase 3 studies to ensure investigator compliance and data quality. Successfully manage FDA relationships with frequent and open communication. Currently managing 9 professionals in Regulatory Affairs/Quality Assurance/Analytical Sciences and corresponding budgets. Manage all quality relationships with contract vendors as part of Steering Committees. Serving as a member of the Joint Development Committee with collaboration partner.

Responsible for all interactions and submissions with the FDA and European authorities for CE marking of the GlucoWatch G2 Biographer (a FDA class III device and a CE marked Class IIb device) and the GlucoWatch Analyzer software. FDA interactions have included preparation and submission of the modular PMA, FDA panel meeting, FDA face-to-face meetings on Regulatory issues, and submission of several post approval FDA supplements and Annual Reports for the GlucoWatch G2 Biographer and the GlucoWatch Analyzer software. Established a credible and professional relationship with FDA’s IVD group. Other FDA interactions include preparation and managing of several FDA inspections including Pre-Approval Inspections according to the QSIT approach, post-approval inspections for complaints and MDRs, and bioresearch monitoring (BIMO) inspections at clinical investigator and sponsor sites.

Ph.D., Chemistry

B.S., Chemistry