1963 Fleming Street
Montgomery, AL 36117
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
- to respond to regulatory submission concerns of other departments, in an effective manner
- Ability to bookmark, archive, and track regulatory submission documents, properly
Computer Sciences Corporation, Montgomery, AL
August 2012 – Present
- 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.
PAREXEL International, Montgomery, AL
May 2009 – July 2012
- 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.
Bachelor’s Degree in Information Technology
Lesley University, Cambridge, MA