Ernest Richard Kitt

WORK HISTORY

EDUCATION

ABOUT ERNEST RICHARD KITT

An executive specializing in all levels and functions of drug development from Phase 1- Phase 4 clinical programs and also specializing in process and procedure development, Regulatory Affairs and Quality Assurance with with an understanding all of the challenges across the board in development and getting products across the finish line for approval or to expand the product profile of critical company assets- 20+ years of progressive drug development, and executive supervisory experience in managing teams, molecules, and programs for domestic and international/global development programs- Successful NDA, BLA, IND, and ODD Submissions, Allowances, and Approvals - Experience in API Development for Drug Substance and Formulation for Drug Product - Ability to manage executive decisions and effectively bridge groups together to come to agreements to execute deliverables- Successful record in Regulatory Affairs & managing all functional groups for the removal of such regulatory issues as FDA clinical hold(s)- Ability to think strategically by quickly identifying and acting on opportunities, and combining forethought with action- Developed and Launched Quality Systems for GxP and GCP operations, including the implementation of SOPs and Policies for Development- Flexibility and the ability to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment- Extensive knowledge and experience with in FDA communications and submissions, CFRs, GCP and GxP guidelines and regulations- Acting decisively in management by making decisions effectively and on time, and the ability to foster the same in others- Driving performance by holding self and others accountable for the achievement of performance expectations- Strong initiative in decision-making and assumption of responsibilities- Outstanding leadership skills with strong focus on developing highly functioning multidisciplinary teams and team-oriented environments- Ability to operate, adapt and influence more complex organization.