Timothy A. Dotson, M.S. Email and Phone Number
Timothy A. Dotson, M.S. work email
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Timothy A. Dotson, M.S. personal email
Accomplished regulatory affairs professional skilled at achieving pesticide product registrations through the U.S. EPA and new animal drug product approvals through the FDA’s Center for Veterinary Medicine (FDA/CVM). Strong technical qualifications with an impressive track record of more than 20 years of hands-on experience in regulatory affairs, including EPA FIFRA and FDA FFDCA; FDA/CVM new animal drug and EPA/OPP pesticide laws, regulations, guidelines, and policies; toxicology; safety & risk assessment; chemical regulation; and state and federal compliance.
Regulatory Compliance Solutions Llc
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- regcompliancesolutions.com
- Employees:
- 1
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PresidentRegulatory Compliance Solutions Llc Jul 2016 - PresentSugar Hill, GaRCS is an integrated regulatory consulting firm providing customized solutions for your regulatory needs for EPA pesticide products and FDA/Center for Veterinary Medicine (CVM) new animal drugs. Our dedicated staff has 20+ years in the pesticide and animal health industries. From the most basic to more complex strategies, we have the skills to successfully get your product through the regulatory process in a timely fashion. Our knowledge of the laws and regulations governing pesticides and new animal drugs, combined with years of practical experience working with federal, state and local agencies, will help your company avoid the regulatory pitfalls that cost time and money. At RCS, our goal is to streamline the regulatory process and get your product to market sooner. Call us at 404-698-7199 or email at tim.dotson@regcompliancesolutions.com for more information. Also see website for more details: http://www.regcompliancesolutions.com
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DirectorKindred Biosciences Nov 2015 - Jul 2016Burlingame, CaliforniaAs Director of Regulatory Affairs managed all aspects of FDA approval for new animal drugs, including small molecules and biologics. Managed regulatory personnel and coordinated timely submission of new animal drug technical sections to FDA/CVM. Participated in Management Steering Committee meetings to discuss regulatory issues that may affect the business. Developed post-approval processes and SOPs for anticipation of the company’s first FDA/CVM approval, a new animal drug for control of pyrexia in horses. Asked to lead company in all post-approval regulatory activities, including creation of a new post-approval regulatory group. Developed the company’s first EU marketing authorisation for a new animal drug for control of weight loss in cats. Liaison for both EMA and the FDA/CVM in all matters related to both EU and US submissions.
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Executive Director, Regulatory Affairs & CmcJaguar Animal Health Sep 2014 - Oct 2015San Francisco Bay AreaAs Executive Director of Regulatory Affairs & CMC I managed all aspects of FDA approval for new pharmaceutical products in an animal health company specializing in botanical drugs used to treat gastrointestinal conditions in dogs, cats and horses. Point of contact with FDA/CVM for managing all aspects related to filing and approval of new pharma projects. Achieved Minor Use, Minor Species (MUMS) determination for the use of crofelemer in treating dogs with chemotherapy-induced diarrhea. -
Director, Regulatory AffairsMerial Limited Apr 2002 - Sep 2014Duluth, GeorgiaAs Director of Regulatory Affairs US, I managed all EPA projects in addition to new pharmaceutical projects in a leading global animal health company. Active in project teams for development and submission of pesticide applications to the US EPA, and technical sections for New Animal Drug Applications (NADAs) to the FDA/CVM. Obtained EPA approval for two new end-use products and one manufacturing-use product, in addition to numerous new clinical efficacy and safety claims for the FRONTLINE brand of products. Achieved FDA/CVM approval for two equine drug products in addition to NEXGARD soft chewable for fleas and ticks. For EPA and new pharma projects, collaborated with R&D, CMC, Safety Assessment, Industrial Operations, Manufacturing, Quality Assurance, Supply Chain, Formulations Development, Analytical R&D, and Clinical Operations. -
Manager, Regulatory Affairs NaUcb Chemicals Corporation 1997 - 2002Marietta, GeorgiaManaged day-to-day regulatory affairs operations of a $28MM global division specializing in the manufacture and sale of commercial and specialty pesticides and industrial amines. Liaison for various government authorities including US EPA, FDA, USDA, DEA, etc. Over 12 years of experience involved in management of international, federal and state pesticide registrations, risk assessment and toxicology, including consulting experience for agrochemical, chemical, and pharmaceutical companies. Served as company representative in 7 distinct roles for 5 pesticide industry consortiums. Responsible for NA regulatory affairs division with interactions with Latin American Region, Canadian and European affiliates.
Timothy A. Dotson, M.S. Skills
Timothy A. Dotson, M.S. Education Details
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3.8/4.0 -
Microbiology
Frequently Asked Questions about Timothy A. Dotson, M.S.
What company does Timothy A. Dotson, M.S. work for?
Timothy A. Dotson, M.S. works for Regulatory Compliance Solutions Llc
What is Timothy A. Dotson, M.S.'s role at the current company?
Timothy A. Dotson, M.S.'s current role is President at Regulatory Compliance Solutions LLC.
What is Timothy A. Dotson, M.S.'s email address?
Timothy A. Dotson, M.S.'s email address is ti****@****ial.com
What schools did Timothy A. Dotson, M.S. attend?
Timothy A. Dotson, M.S. attended American University, Virginia Polytechnic Institute And State University.
What skills is Timothy A. Dotson, M.S. known for?
Timothy A. Dotson, M.S. has skills like Development, Animal Health, Development Projects, Veterinary Medicine, Regulatory, Regulatory Affairs, Life Sciences, Quality Assurance, Lifesciences, Pharmaceutical Development, Drug Development, Pharmaceutics.
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