Dimitar Ivanov
Sr Manager, Regulatory Affairs @Fresenius Kabi USA
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WORK HISTORY
Sr Manager, Regulatory Affairs @Fresenius Kabi USA
Lake Zurich, IL, US
Leads a team of Regulatory Technical Managers and manages a product portfolio of complex and combination (drug-device) generic products under development and review with US FDA (focus areas - Oncology, Critical Care and Anti-Infectives)
EDUCATION
University of Wisconsin-Parkside
B.S., Molecular Biology & Bioinformatics
Northwestern University
Ph.D., Biological Sciences from the Interdepartmental Biological Sciences (IBiS) Program
SKILLS
ABOUT DIMITAR IVANOV
I am an established professional with diverse problem-solving skills in Life Sciences, Clinical Research and Regulatory Affairs. My relentless focus on quality, my strive to consistently meet and exceed project-related deliverables, and my ability to communicate effectively with clinical, business and regulatory stakeholders have allowed me to successfully address current challenges in clinical trial management and in drug, biologic and medical device registration.Specialties: • Development and maintenance of regulatory dossiers• Scientific and clinical data review, mining, interpretation and analysis• Quality control & internal auditing of clinical trial data• Oracle Clinical RDC, SAS, MS Suite & Abode Illustrator proficiency• Project management, scientific writing and presentation
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