Regulatory Publisher Resume

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Here is the Regulatory Publisher Resume example:

Frank Jones

1963 Fleming Street

Montgomery, AL 36117

(222) 369-7589

[email]

Job Objective Pursuing the opportunity to enhance my career and use my skills to their fullest by securing a Regulatory Publisherposition with reputable company.

Highlights of Qualifications:

  • Hands-on experience in handling and publishing of electronic and paper-based regulatory documents
  • Profound knowledge of regulatory publishing standards and procedures
  • Outstanding knowledge of current regulatory submission requirements
  • Familiarity with using Microsoft Office Suite, NextDocs, and eCTD Express
  • ?bility

  • to respond to regulatory submission concerns of other departments, in an effective manner
  • Ability to bookmark, archive, and track regulatory submission documents, properly

Professional Experience:

Regulatory Publisher

Computer Sciences Corporation, Montgomery, AL

August 2012 – Present

Responsibilities:

  • Created and implemented effective publishing and formatting standards for regulatory submissions.
  • Formatted, published, and submitted all assigned regulatory documents, on time.
  • Organized, bookmarked, monitored, and maintained all regulatory files for submission.
  • Checked and validated all regulatory documents for correctness and completeness.
  • Interpreted and adhered to all applicable FDA, GCP, and ICH guidelines.
  • Developed and maintained positive relationships with coworkers and regulatory authorities.

Regulatory Publisher

PAREXEL International, Montgomery, AL

May 2009 – July 2012

Responsibilities:

  • Prepared and tracked all submission project documentation, in an efficient manner.
  • Indexed, organized, and reviewed all assigned regulatory documents and forms.
  • Used eCTDXPress and Documentum software and processed regulatory documents, properly.
  • Developed and evaluated work-related SOPs and training materials, as required.
  • Complied with FDA guidelines and followed regulatory specifications.
  • Communicated and worked with Regulatory Affairs and Regulatory Managers, in a positive manner.

Education

Bachelor’s Degree in Information Technology

Lesley University, Cambridge, MA

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  • March 1, 2020Create Date
  • March 1, 2020Last Updated