
Consultant
Carolyn joined EDGE from Zoetis, Inc. After several years in R&D at Fort Dodge Animal Health, she moved to Regulatory Affairs to support new and existing biologics in the EU and US. Under Zoetis, she provided Regulatory Compliance support at a manufacturing site. She brings experience in quality systems, deviation reporting, and facility compliance management.
Contact Info
Carolyn Ross
EDGE Veterinary Vaccines Consulting Group, LLC
340 C Ave
Ogden, IA 50212
515-351-8669
CRoss@edgevcg.com
Education
- University of Illinois at Chicago, MS Microbiology and Immunology, 1994
- Iowa State University, BS Microbiology and Immunology, 1990
EDGE Veterinary Vaccines Consulting Group, LLC 02/2016-Present
Vice President for Regulatory Strategies
EDGE specializes in Veterinary Biologics including all aspects of Regulatory Affairs from company start-up to global expansion, development planning, study design and report generation, problem solving (R&D, manufacturing and QC), emerging diseases, training and development, mergers and acquisitions, Department of Commerce EAR requirements and international harmonization.
Zoetis, Inc. (formerly Pfizer Animal Health) 2011-2016
Manager/Team Lead Regulatory Compliance, USDA liaison. Regulatory support of USDA licensed establishment; technical and regulatory support for global registrations and product life-cycle management.
Pfizer Animal Health 2009-2011
Senior Manager, Biological Regulatory Affairs
USDA liaison. Regulatory support of former Fort Dodge Animal Health products during the transition of licensure to Pfizer Animal Health.
Fort Dodge Animal Health 2004-2009
Senior Manager, Biological Regulatory Affairs
USDA liaison. US regulatory strategy for exported products authorized under DEREA, FFM and FEO. Technical support and regulatory strategy for new product registration and variations to licensed products in the European Union.
Fort Dodge Laboratories 2001-2004
Assistant Manager, EU Regulatory Affairs
Technical support and regulatory strategy new product registrations and variations to licensed products in the European Union.
Fort Dodge Laboratories 1998-2001
Project Leader, Research and Development. Led research team for development of veterinary vaccines, focus area bovine bacteriology.
Fort Dodge Laboratories 1997-1998
Principal Scientist, Research and Development.
Fort Dodge Laboratories 1995-1997
Senior Technician, Research and Development.Senior Technician, Research and Development.Senior Technician, Research and Development.
Fort Dodge Laboratories 1994-1995
Technician, Research and Development