Regulatory Operations Specialist Submissions Expert

ELIZABETH A. BENSON

Chester, Pennsylvania ***** 835-***-**** ***********@*****.***

SUMMARY

An accomplished and results-driven regulatory operations professional with extensive experience in submission publishing, purchasing, production, and regulatory compliance within the pharmaceutical industry. Established capabilities in organizing and managing information to meet critical deadlines, using various technologies while maintaining strong cross-functional relationships. Provides regulatory submission services for clients in pharmaceutical and biotechnology industries. Leverages excellent communication, interpersonal, and problem-solving skills to achieve operational excellence. Serves as a key contributor to the success of the organization.

EXPERIENCE

ENDO PHARMACEUTICAL, INTERNATIONAL Malvern, Pennsylvania

Regulatory Operations Specialist 2017-2025

Led preparation and publishing of electronic regulatory documents and submissions, ensuring deliverables were compliant with health authority guidelines.

Archived regulatory correspondence and prepared and submitted periodic adverse events reports (PADERS), PADER Waivers, promotional materials, and maintenance of databases within regulatory affairs department.

Prepared regulatory submissions to various health authorities in compliance with appropriate company business processes and external regulations / specifications.

Submitted eCTD submissions to health authorities and tracked related information in department databases.

Published (e.g., converted to PDF, bookmark, hyperlink) individual regulatory documents as needed and remained current on internal / external electronic submission initiatives and requirements.

Prepared and submitted periodic adverse drug experience reports in accordance with current FDA requirements.

Identified and implemented enhancements in business processes with other departments to ensure all eCTD submissions met health authority requirements.

Assessed electronic submission capabilities and provided feedback to regulatory management to improve efficiency.

Monitored regulatory operations inbox for promotional materials, periodic safety reports (PSR) and daily submission for pharmaceutical’s colleagues in New York and Michigan for ANDAs, NDAs, and BLAs.

Created sequences in eCTDXpress to begin or add to lifecycle of application; published and validated all submissions.

Conducted quality checks on all submissions before second quality check by colleague and moved on to complete process.

DXC TECHNOLOGY (FORMERLY CSC) Ashburn, Virginia

Senior Regulatory Publisher 2014-2017

Provided regulatory submission services for clients in pharmaceutical and biotechnology industries.

Oversaw and coordinated processing of electronic submissions to ensure compliance with document management standards.

Created lifecycle sequences to submit to governing health authorities.

Trained new team members, demonstrating good judgment in selecting methods and techniques for obtaining solutions.

Managed electronic communication and submission processes, including general correspondence, reports, and amendments.

Provided support to pre-sales team. Created and monitored SOWs from new and old clients.

ADDITIONAL EXPERIENCE

OTSUKA PHARMACEUTICALS, Princeton, New Jersey, Regulatory Submission Specialist, 2014. Provided guidance and consistency for publishers when quality checking navigation within report level publishing deliverables. Communicated with publishers of all findings to be addressed by medical writer, internal publisher, or external publisher. Provided quality checklist and issue log for every assignment. Uploaded documents in SharePoint for review. Communicated with team to ensure all issues were resolved and in compliance.

ASTRAZENECA PHARMACEUTICALS, Wilmington, Delaware, Clinical Submission Specialist, 2007-2014. Published and submitted serious adverse events through gateway directly to FDA on daily basis. Served as leader of adverse event team in clinical department. Represented clinical and patient safety to regulatory for implementing process changes. Trained other CSS on processing of adverse events. Conducted informational meetings monthly. Delivered on average of 150 adverse events per month.

WYETH PHARMACEUTICALS, Collegeville, Pennsylvania, Submission Publisher I, 2000-2007. Compiled documents for inclusion in future submissions. Published ad hoc, NDA, and IND submissions. Prepared electronic outlines and applied required cross-referencing, bookmarking, and hypertext linking to ensure accurate navigation. Produced high-quality submissions, using eCTD publishing tool. Performed audit of all documents, ensuring the integrity of audit trial in Electronic Document Management Systems (EDMS).

EDUCATION

WIDENER UNIVERSITY, Chester, Pennsylvania

B.S., Professional Studies, Minor in Applied Supervision

DELAWARE COUNTY COMMUNITY COLLEGE, Media, Pennsylvania

A.A., Business Management

PROFESSIONAL DEVELOPMENT

Certificate of Competency in HR Management, Delaware County Community College

Business Education, MRP Certification, Penn State University

TECHNICAL SKILLS

Microsoft Office Suite SharePoint Electronic Document Management Systems (EDMS)

AFFILIATIONS

Toastmasters International

Healthcare Ministry

Drexel Neumann Academy Scholarship Committee and Home and School Association

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