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James Little

Nonclinical and Regulatory Affairs professional with 27 years FDA-regulated product development experience. Expertise includes nonclinical drug, biologic,... | Boulder, Colorado, United States

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James Little’s Location Boulder, Colorado, United States

James Little’s Expertise Nonclinical and Regulatory Affairs professional with 27 years FDA-regulated product development experience. Expertise includes nonclinical drug, biologic, and device development supporting conventional as well as chemical, biological, radiological and nuclear (CBRN) threat indications. Regulatory affairs (RAC) and quality assurance-certified (RQAP-GLP) professional accomplished in quality compliance (GLP/GCP/GMP), risk evaluation and mitigation, strategic regulatory path planning, contract and project management, and all drug regulatory operation activities.

James Little’s Current Industry Biomedical Advanced Research Development Authority Barda Us Department Of Health And Human Services

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Work Experience

Biomedical Advanced Research Development Authority Barda Us Department Of Health And Human Services

Chief, Nonclinical Data Operations

Tue Oct 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Present

Biomedical Advanced Research Development Authority Barda Us Department Of Health And Human Services

Acting Director, Regulatory And Quality Affairs Division

Wed Feb 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Sep 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Biomedical Advanced Research Development Authority Barda Us Department Of Health And Human Services

Deputy Director, Regulatory And Quality Affairs

Wed Jan 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)

Biomedical Advanced Research Development Authority Barda Us Department Of Health And Human Services

Regulatory Affairs Specialist

Tue Nov 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)

Saic

Regulatory Affairs Advisor

Sun Aug 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Nov 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)

Aclairo Pharmaceutical Development

Consultant, Regulatory Affairs And Compliance

Fri Jun 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jul 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)

Aeris Therapeutics

Regulatory Affairs Manager

Wed Jun 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jun 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time)

Praecis Pharmaceuticals

Senior Toxicologist

Mon Jul 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jun 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)

Schering Plough Research Institute

Associate Scientist

Sun Jun 01 1997 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jun 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time)

Utah Biomedical Research Laboratory

Research Associate

Wed May 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Apr 01 1997 00:00:00 GMT+0000 (Coordinated Universal Time)

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James Little Email Addresses

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FAQ About James Little

James Little is located at
Boulder, Colorado, United States

James Little is a
Nonclinical and Regulatory Affairs professional with 27 years FDA-regulated product development experience. Expertise includes nonclinical drug, biologic, and device development supporting conventional as well as chemical, biological, radiological and nuclear (CBRN) threat indications. Regulatory affairs (RAC) and quality assurance-certified (RQAP-GLP) professional accomplished in quality compliance (GLP/GCP/GMP), risk evaluation and mitigation, strategic regulatory path planning, contract and project management, and all drug regulatory operation activities. Biomedical Advanced Research Development Authority Barda Us Department Of Health And Human Services

James Little currently works in the
Biomedical Advanced Research Development Authority Barda Us Department Of Health And Human Services

James Little specializes in
Nonclinical and Regulatory Affairs professional with 27 years FDA-regulated product development experience. Expertise includes nonclinical drug, biologic, and device development supporting conventional as well as chemical, biological, radiological and nuclear (CBRN) threat indications. Regulatory affairs (RAC) and quality assurance-certified (RQAP-GLP) professional accomplished in quality compliance (GLP/GCP/GMP), risk evaluation and mitigation, strategic regulatory path planning, contract and project management, and all drug regulatory operation activities.

James Little speaks the following languages:
No languages available.

James Little has prior experience in the following industries:
Biomedical Advanced Research Development Authority Barda Us Department Of Health And Human Services , Biomedical Advanced Research Development Authority Barda Us Department Of Health And Human Services , Biomedical Advanced Research Development Authority Barda Us Department Of Health And Human Services , Saic , Aclairo Pharmaceutical Development , Aeris Therapeutics , Praecis Pharmaceuticals , Schering Plough Research Institute , Utah Biomedical Research Laboratory

James Little has the following professional experience:
Biomedical Advanced Research Development Authority Barda Us Department Of Health And Human Services , Biomedical Advanced Research Development Authority Barda Us Department Of Health And Human Services , Biomedical Advanced Research Development Authority Barda Us Department Of Health And Human Services , Biomedical Advanced Research Development Authority Barda Us Department Of Health And Human Services , Saic , Aclairo Pharmaceutical Development , Aeris Therapeutics , Praecis Pharmaceuticals , Schering Plough Research Institute , Utah Biomedical Research Laboratory .