Dawn Kimble
Pharmacist- Office of Generic Drugs Regulatory Project Management at Fda
Based in Reisterstown, United States
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Seniority
Other
Department
Other
Location
Reisterstown
Industry
Architecture and Planning
Company size
18
Contact information
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d•••••••@fd-a.co.za
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Background
About Dawn Kimble
10+ years in Office of Generic Drugs managing the drug application process from acceptance to approval. • Experience in coordinating multi-discipline reviews, to meet GDUFA timelines, commitments and leverage the Hatch-Waxman Act to ultimately help patients have lower drug costs. • Primary liaison between the agency and drug company to assist with go-to market strategy. • Trainer in GDUFA reauthorization for Small Business Industry Assistance to enhance amendment submission and review cycles. • 15+ years experience leading global initiatives in Healthcare and Consumer Goods industries. • 18+ years of Research & Development experience focused on technology and consumer research. • 15+years experience managing and driving global teams to meet/exceed company business objectives. • Responsible for 80+ product launches that contributed multi-millions of dollars to company bottom line. • Experience leading and influencing multifunctional teams to deliver projects, define and develop processes that achieve business results • Proven track record of product development lifecycle expertise to manage multiple launch cycles concurrently. Contact info: purpledawnkv@yahoo.com
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