Cheryl G. Email & Phone Number

Experienced Regulatory Operations Professional with recognized ability to successfully plan for and manage multiple marketing applications while overseeing the routine daily maintenance of existing IND/CTA applications. Demonstrated experience working with eCTD publishing systems and related publishing/PDF processing, submission planning, and document management tools and systems. Proven skills managing project/submission timelines and organizing resources as part of a cross-functional team, while adapting quickly to changing requirements and deadlines. Well organized with meticulous attention to detail and strong analytical/troubleshooting skills. Knowledgeable in global eCTD structure and technical submission requirements for multiple regions, including US, Canada, UK, and EU. Strong communication and collaborative skills and an understanding of the complexities around early and late-stage drug developmentTechnical Skills: Veeva Vault RIM: Submissions, Archive, Content Planning (successfully completed Platform and Submissions Fundamentals, Business Administrator and System Administrator training courses); Smartsheet; QDossier: Dossplorer eCTD Viewer; ACUTA ARIM (now IQVIA RIM Smart): Publishing & Validation, Viewer, Correspondence & Commitments, and Registration modules, ACUTA PDF Tools; Liquent: S-Cubed, eCTD Viewer Web Edition; Adobe Acrobat Standard and Professional; DXC (ISI/TRS/CSC) Toolbox; Microsoft Office: Word, Excel, PowerPoint, Outlook; QUMAS DocCompliance

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  Northeastern University

  Biology