Charnelle Thomas, MS, RAC, CQA

Experience

• 

  Solvay Pharmaceuticals, Inc.

  Mar 2005 - Jan 2007

  REGULATORY SYSTEMS ASSOCIATE

  Served as US local liaison to IT and provided CoreDossier support to the US Regulatory Submissions group. Investigated and implemented new software to increase efficiency in submission-related activities. Developed document standards manuals for regulatory submissions. Authored user acceptance testing scripts and executed user acceptance tests for new technologies. Evaluated and redeveloped regulatory processes to increase efficiencySelected Accomplishments:Served as a key player in the compilation of the company's first eNDA which included the development of training materials and conducting training sessions to the Clinical and Submissions group on the usage of ISI ToolboxPlayed a key role on the Global Regulatory Affairs SOLID subteam which was a global initiative to upgrade to a Global EDMS. This was achieved by facilitating global collaboration on Global Operating Procedures, serving as a member of the Migration Team to migrate legacy documents to new system and serving on the CoreDossier Upgrade Team which oversaw the transition from a local to global publishing tool. This initiative successfully combined over 5 electronic document management systems Show less

• 

  Abbott Products Inc. formerly Solvay Pharmaceuticals, Inc.

  Jan 2007 - Sept 2011

  Regulatory Submission Specialist

  Execute and manage publishing activities for a wide range of local and global regulatory submission types, including new drug applications, amendments, supplements and annual reports. Track submission metrics and analyses for process improvement. Play integral role in eCTD transition activities. Lead and direct process improvement initiatives to increase efficiency in submission compilation processesSelected Accomplishments:Played an integral role in company initiative to transition from paper to eCTD submissions by liaising with global submissions experts to redevelop all submission processes, designing web-based interactive trainings using Adobe Captivate, and successfully leading global training initiatives for the implementation of new eCTD templates company-wide. This initiative resulted in the successful submission of over ten eCTD submissions globally. Usage of web-based trainings also contributed to the achievement of the company-wide goal to decrease operating expenses by 20%Assumed the role of annual report coordinator and redeveloped the annual report process to increase timeliness of annual reports from 60% to 100%. Achieved this by leading the implementation of new annual report templates, revising the compilation process, developing training materials and administering functionality training to over 100 users globallyAuthored various submission-ready guides including a guide for remediating legacy nonclinical and clinical study reports, trained submissions team globally using this guide and successfully led a project team in the remediation of over 150 reportsContributed to the successful development of approximately 30 web-based training modules, regulatory training presentations, job aids, work instructions, and global operating procedures Show less

• 

  Kimberly-Clark

  Oct 2011 - Sept 2017

  Provide technical leadership in the development and implementation of regulatory strategies to support the achievement of business objectives, while ensuring compliance with domestic and international drug, device, and cosmetic regulationsProvide regulatory training and strategic regulatory assessments to the research and development teams in support of new technology development that is cognizant of product testing and other requirements for regulatory approval in global marketsEstablish and maintain harmonized global regulatory management systems designed to effectively and efficiently support global business objectives Show less

  • Global Regulatory Affairs Technical Leader II

    Jun 2014 - Sept 2017

  • Global Regulatory Affairs Technical Leader I

    Aug 2013 - May 2014

  • Global Regulatory Affairs Specialist

    Oct 2011 - Jul 2013
• 

  MiMedx

  Sept 2017 - Nov 2019

  Regulatory Affairs Manager

  Coordinate and assist in the preparation of technical documentation for use in regulatory registrations and submissions worldwide. Products currently include: tissue products, medical devices, and biologicals Develop additional regulatory knowledge of worldwide guidelines, standards, and regulationsExecute and manage publishing activities for global regulatory submissions including DMFs, INDs, BLAs and 510ks

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  Chemence Medical, Inc.

  Nov 2019 - now

  • Vice President of Regulatory Affairs

    Jan 2022 - now

  • Director of Regulatory Affairs

    Nov 2019 - Feb 2022