Experience

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  The J.M. Smucker Co.

  • Orrville, Ohio, United States

  • Senior Scientist

    • Jan 2022 - Present
    • Orrville, Ohio, United States

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  Mars Petcare

  • Franklin, TN

  • Scientific and Regulatory Affairs Senior Scientist

    • Aug 2014 - Apr 2022
    • Franklin, TN

    My current responsibilities include ensuring the regulatory compliance of numerous brands including all wet cat brands, natural dog brands and our science based dry cat brand. I review the scientific substantiation of claims and collaborate with multi-functional teams in the development of claims and claims support, provide scientific and regulatory assessments of internal and external studies, collaborate with R&D on study design and prepare regulatory and technical responses to regulatory and competitive challenges. I review all ingredient specifications for regulatory and technical accuracy and evaluate the natural status of ingredients. I also prepare and manage regulatory submissions to FDA and AAFCO. I have developed and presented training for R&D associates on the regulatory environment, claims and claims substantiation. In addition, I research and evaluate new ingredients and nutritional technologies and design new products, establishing both regulatory compliance and product efficacy standards.

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  Procter & Gamble

  • United States
  • Manufacturing
  • 700 & Above Employee

  • Senior Scientist Regulatory Affairs

    • Jul 2004 - Aug 2014

    Ensured technical and scientific supportability of claims. Led multi-functional team (Marketing, Product Development, Regulatory and Legal) in development of claims and claims support documentation for label and advertising copy. Collaborated with R&D scientists and project managers regarding design parameters for safety and efficacy studies. Prepared technical and regulatory responses to inquiries and challenges from regulators globally that allowed registration and marketing of products in North America, Europe, Japan and China Developed technical and regulatory strategy which eliminated need for 40-45 weeks of animal testing annually. Developed technical and regulatory arguments required to successfully challenge competitors' advertising that adversely affected sales. Developed study reports and technical summaries for FDA submissions. Managed FDA and EFSA submissionsCreated FDA plant inspection manual and conducted training critical in allowing all company pet food manufacturing facilities to pass FDA inspections.Advised management on regulatory status of and created regulatory strategies for new ingredients and products. Conducted training on regulations, regulatory documentation, inspections and document management software.

  • Veterinary Communications Development Manager

    • May 2000 - Jun 2004

    Coordinated release technical information to professional and consumer audiences. Developed technical materials for use by veterinary field sales/marketing to support product sales. Wrote and edited scientific articles for veterinary publications. Generated summaries of clinical research for internal and external use. Managed outside writers.

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  Blue Seal Feeds

  • Manchester, NH

  • Nutritionist /Technical Support

    • Aug 1998 - Apr 2000
    • Manchester, NH

    Balanced dairy, beef and equine rations and designed custom mixes and commodity blends. Designed and introduced several successful new products. Wrote and presented talks on dairy nutrition and management at producer meetings. Assisted sales representatives with on-farm sales presentations. Provided on-farm nutrition and management troubleshooting for customers.

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  Moormans Inc./Archer Daniels Midland Company

  • Eau Claire, Wisconsin Area

  • Dairy Specialist

    • Oct 1993 - Jun 1998
    • Eau Claire, Wisconsin Area

    Implemented 5 Star Customer Service Program which increased customer retention by 25 percent. Assisted sales representatives with on-farm sales presentations. Provided on-farm nutrition and management troubleshooting for customers. Wrote articles for company technical bulletin and regional newsletter. Created mineral demonstration that helped increase mineral sales 20 percent. Designed, created and produced dairy newsletters, product literature and presentation materials. Wrote and appeared in mineral quality video. Balanced dairy, beef and equine rations and designed custom mixes and commodity blends. Designed and introduced several successful new dairy products. Wrote and presented talks on dairy nutrition and management at producer meetings. Chaired Dairy Initiative and Dairy Technical Task Forces. Conducted nutrition, ration balancing and dairy management training sessions for sale representatives

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  FDA, Center for Veterinary Medicine

  • Rockville, MD

  • Animal Scientist

    • Mar 1988 - Sep 1993
    • Rockville, MD

    Developed expertise in approval process and data requirements of food additives, medicated feeds and veterinary drugs. Assisted petitioners in study protocol development for food additives. Formulated procedures for evaluating novel feed ingredients and/or uses. Reviewed, evaluated, and furnished scientific opinions on acceptability of labeling, ingredients and formulation of feed products. Created and implemented document tracking database. Wrote and presented speeches on regulation of feeds and food additives. Reviewed and evaluated Food Additive Petitions. Aided in the implementation of the feed portions of Free Trade Agreement