Jim Wachholz
Sr Director Regulatory Affairs Product Developer Market Access @Fortrea
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WORK HISTORY
Sr Director Regulatory Affairs Product Developer Market Access @Fortrea
Cambridge, MA, US
EDUCATION
DePaul Driehaus College of Business
MBA, Marketing/ Finance
National University of Ireland, University College Dublin
Professional Certificate, International Business/Trade/Commerce
Northern Illinois University
BS, Biology/ Chemistry
SKILLS
ABOUT JIM WACHHOLZ
Experienced Pharmaceutical/ biotechnology new drug development Regulatory Affairs professional. A demonstrated history of management achievement in the analysis, strategic planning, regulatory affairs support from product portfolio selection through development to commercialization. Focused on regulatory strategic planning, Incorporating and implementing expedited development pathways (Orphan/Rare Disease, Prime/Fast Track, Breakthrough Therapeutic Designation), for pharmaceutical and biotechnology new product development. Overall Development Program review and clinical trial design assessment to insure maximal labeling claims.Skilled in GLP/ GCP/GMP, Devices, Biotechnology, Regulatory Risk Management, Expanded Access. Expert in U.S. Food and Drug Administration (FDA) and EMA policies/procedures. Strong business development professional with MBA (DePaul Univ Kellstadt GSB), Professional Certification in International Business Management from National University of Ireland, University College Dublin.
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