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Sheila R. Plant, PhD, MHS, RAC

Vice President, Regulatory Affairs
Allucent

Dr. Sheila Plant has over 27 years of experience in biomedical sciences, including more than 18 years in regulatory affairs and clinical research and has extensive knowledge of the overall drug and medical device development process. At Allucent, Dr. Plant is responsible for assisting clients with the regulatory activities of drug, biologic, or medical device products and has led marketing application projects leading to FDA approval for drug and drug-device combination products. She provides counsel to and manages regulatory teams; ensures timely preparation of organized and scientifically valid submissions; translates regulatory requirements into practical, workable plans; and leads or participates in FDA interactions including correspondences, teleconferences, and meetings. Responsibilities include provision of strategy, review, and authoring of regulatory and scientific documents.

Prior to her joining Allucent, she served as Regulatory and Start-Up (RSU) Specialist and Regulatory/Clinical Coordinator for Quintiles and Gastrointestinal Oncology Research Duke Cancer Institute, respectively. Dr. Plant earned her Ph.D. in neurobiology from the University of North Carolina in Chapel Hill and her Master’s in Health Sciences (MHS) from the Clinical Research Training Program at Duke University Medical Center. She is also certified by the Regulatory Affairs Professional Society (Regulatory Affairs Certificate, RAC).

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