Laura Kilgore leads regulatory affairs for chemistry, manufacturing, and controls. Additionally, she specializes in providing strategic input, project management, and technical writing support for the development of agency meeting requests, original investigational new drug applications and new drug applications, and briefing documents. Ms. Kilgore has extensive experience in providing regulatory chemistry, manufacturing, and controls and quality leadership for development products supporting marketing approvals, as well as in lifecycle management for a broad range of marketed products across pharmaceutical, biologic, and medical device products, including solid oral dosage forms, topicals, transdermals, combination products, biosimilars, and devices. She spent six years at Actavis Laboratories and more than 10 years at Nektar Therapeutics in regulatory affairs and quality assurance. Ms. Kilgore holds a bachelor’s degree in chemistry, magna cum laude, from Auburn University and has Regulatory Affairs Certification for the United States.
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