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