Position:
Director / Global Regulatory Lead - Immunology, CNS, and Oncology at AbbVie
Work:
AbbVie
- North Chicago, IL since Nov 2011
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Director / Global Regulatory Lead - Immunology, CNS, and Oncology
Dendreon Corporation
Aug 2010 - Nov 2011
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Director of Regulatory Affairs, Atlanta Immunotherapy Manufacturing Facility
Reata Pharmaceuticals (Dallas, TX)
Jun 2008 - May 2009
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Senior Director of Regulatory Affairs and QA
Actelion (South San Francisco, CA)
Jul 2007 - Jan 2008
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Senior Director of Regulatory Affairs
Novalar Pharmaceuticals (San Diego, CA)
Jan 2006 - Dec 2006
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Vice President of Regulatory Affairs and QA
CancerVax (San Diego, CA)
Nov 2004 - Oct 2005
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Senior Director of Regulatory Affairs and QA
Biogen Idec (San Diego, CA)
Jul 2000 - Nov 2004
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Director of Regulatory Affairs
MAXIA Pharmaceuticals (San Diego, CA)
Feb 1998 - Jul 2000
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Director of Regulatory Affairs and QA
Anergen (Redwood City, CA)
Feb 1997 - Feb 1998
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Associate Director of Regulatory Affairs and QA
Biometric Research Inst / Quintiles (Washington, D.C.)
Mar 1996 - Feb 1997
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Manager of Regulatory Affairs
Scandipharm / AXCAN Pharma (Birmingham, AL)
Apr 1993 - Mar 1996
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Director of Regulatory Affairs and QA
Solvay Pharmaceuticals / Abbott (Atlanta, GA)
May 1991 - Apr 1993
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Senior Regulatory Affairs Coordinator
Bayer Pharmaceuticals (West Haven, CT)
Jun 1990 - May 1991
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Senior Regulatory Compliance Specialist
The Upjohn Company / Pfizer (Kalamazoo, MI)
May 1984 - Jun 1990
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Quality Assurance Professional III
Mississippi Chemical Corp. (Yazoo City, MS)
Aug 1978 - May 1984
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Research Chemist
Education:
The Johns Hopkins University 2011 - 2014
MS in Bioscience Regulatory Affairs
Mississippi College 1975 - 1978
BS, Chemistry
Skills:
IND, NDA, Regulatory Affairs, FDA, Pharmaceutical Industry, GMP, Clinical Development, Biotechnology, Clinical Trials
Honor & Awards:
DENDREON'S MITCHELL TO SERVE AS EX OFFICIO MEMBER OF GEORGIA BIO'S BOARD OF DIRECTORS (8/2011).
DENDREON'S MITCHELL TO SERVE ON ADVISORY BOARD FOR WORLD TRADE GROUP'S BIOMANUFACTURING SUMMIT 2012 (7/2011), being held on January 30 and 31, 2012, at Hyatt Regency La Jolla, San Diego, CA.
DENDREON'S MITCHELL TO CO-CHAIR GaBio's LAWYERS AND REGULATORY AFFAIRS ROUNDTABLE (10/2010).
Awards:
ABBVIE'S MITCHELL TO SPEAK AT ADVANCEMENTS IN CLINICAL RESEARCH OPERATIONS FOR ONCOLOGY PRODUCTS CONFERENCE IN ALEXANDRIA VA
Mitchell will speak on "REGULATORY BEST PRACTICES: Targeting Simultaneous Approvals of Oncologic Therapies and Companion Diagnostics," on June 20, 2013.