Adeana Dorsey has over two decades of experience in regulatory affairs and compliance within the biopharmaceutical, pharmaceutical, gene and cellular therapy, combination product, and medical device industries across multiple therapeutic areas. Adeana is currently working as the Vice President of Regulatory Affairs- CMC at Morphogenesis, Inc., where they are responsible for executing and managing regulatory submissions throughout various clinical development phases, global marketing applications, and post-approval activities. Prior to this, they held the role of Vice President of Regulatory Affairs- CMC at Akouos. Adeana's previous experience includes roles at Clinipace, where they served as the Executive Director RSD, CMC and Director of Regulatory and Strategic Development, CMC, and Cardinal Health, where they worked as the Director of Chemistry, Manufacturing, and Controls. Adeana also worked at BioTechLogic, Inc. as a Manager of Regulatory and Quality Systems, and at AMD Consulting as the Owner, providing quality system development and regulatory support. Earlier in their career, Adeana was the Associate Director of Quality Assurance at Biomimetic Therapeutics, where they oversaw all aspects of the Quality Assurance department and implemented quality systems in accordance with relevant regulations and standards.
Adeana Dorsey received a Bachelor's degree in Biology, General from Marshall University in 1998. Additionally, they hold certifications in ISO 9001 Lead Auditor, Regulatory Affairs Certification (US) from the Regulatory Affairs Professionals Society (RAPS), and Six Sigma Green Belt from ASQ.
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