Melanie Bell, MS, RAC

Melanie Bell is a biopharmaceutical professional with a strong regulatory and scientific background and proficiency in managing multidisciplinary projects.  She specializes in clinical supply management for chemistry, manufacturing, and controls (CMC) programs in clinical development.  Melanie is experienced in the authorship, management, and submission of U.S., European, and Canadian regulatory documents and in the regulatory lifecycle maintenance of INDs and NDAs.  She has experience in operational CMC program management, including contract facility interaction, reviewing and developing Quality Systems and performing quality assurance (QA) functions such as auditing, coordinating, and performing quality and compliance investigations covering multiple regional compliance requirements, manufacturing change control management, and QA lot release.  Melanie has an M.S. in Bioscience in regulatory affairs from the Keck Graduate Institute of Applied Life Sciences and a B.S. in Genetics from the University of Georgia.  She maintains Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS).