Regulatory Operations consultant with over thirteen years experience in Regulatory Publishing and nineteen years experience in the pharmaceutical industry.

Handled oversight and preparation of NDA, BLA, ANDA, IND, and CTA electronic submissions. Guided global operations team regarding current best practices and lifecycle management. Developed and implemented work processes, including standard operating procedures and work instructions. Handled evaluation, troubleshooting, and testing of RAPID 5.0.1 upgrade, Insight Validator, and RAPID hotfixes. Served as Local Support Administrator (LSA) for document management system, Documentum. Continued to perform duties from previous position. - Published over 500 lifecycle submissions for US eCTDs, over 150 clinical study reports, 250 non-clinical reports, and 100 safety reports (PSUR, DSUR, and RMP). - Managed research and development submission teams through global submissions, including original submissions, major supplements, and lifecycle management. - Provided eCTD kickoff and ongoing training and support to submission teams in preparation of major filings; delivered over 20 training sessions for project teams on eCTD practices, software technologies, and submission requirements. - Submitted nine original eCTD applications and one major efficacy supplement (Ozurdex DME).

Published paper and electronic regulatory submissions and other technical documentation in compliance with regulatory agency guidelines. Served as lead publisher for non-clinical reports, PSURs, and clinical study reports. Provided archiving and gateway submission support. Handled SharePoint system administration.

Handled business warehouse headcount reporting and analytics. Served as only SuccessFactors administrator for all of United States and acted as key technical resource for international locations. Managed SharePoint system administration. Functioned as liaison between HR and internal IS group. Continued to perform duties from previous positions.

Provided technical and functional support of process, data, and Human Resources Information Systems (HRIS) for 8,500 employees. Prepared and published monthly worldwide global headcount report for CEO. Wrote reports, using ERP and SAP Ad Hoc Query reporting tools. Designed and analyzed data and reports for all facets of business. Acted as administrator of HR portal web pages, using Documentum Web Publisher; acted as administrator of Resumix candidate tracking software, including all training and reporting. Created end-user documentation and training materials, using InfoPak. Utilized Excel and other Microsoft applications to present and analyze data from HRIS systems. Acted as HR lead for SAP system upgrade. - Implemented and served as lead administrator of SuccessFactors performance management system. - Developed data audit strategy to ensure data integrity in HRIS systems; provided process improvement recommendations and solutions to increase efficiency of data in system.

Conducted user training for new and existing users of HR software. Managed performance review process for consistency, fairness, and timeliness. Supported recruiting functions by providing information from HRIS system and projects as assigned. Built strong partnerships with management team.

Organized and prepared interviews of potential employees, including sourcing, scheduling, and phone screens. Held responsibility for all internal and external job postings, candidate tracking, and use of SAP and Hiring Gateway.