Aisha Salami
Silver Spring,MD
Summary
Regulatory Submissions & Publishing Specialist with expertise in eCTD submissions, FDA ESG filings, and regulatory compliance. Skilled in Linquent, Lorenz, Smartdesk, and ISI Toolbox, with strengths in document management, SOP development, and troubleshooting validation errors. Possesses strong project management skills, backed by a PMP certification, ensuring efficient coordination of submissions and deadlines across teams.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Regulatory Submissions Specialist
General Dynamics Information Technology (GDIT)
10.2022 - Current
- Manage and execute the compilation, publishing, validation, and submission of regulatory documents in compliance with FDA guidelines.
- Review and process publishing requests to ensure accuracy, completeness, and adherence to client specifications.
- Utilize and maintain expertise in regulatory submission software, including Linquent and Lorenz, to optimize workflow efficiency.
- Prepare and refine PDF documents using advanced publishing tools such as Smartdesk and ISI Toolbox.
- Develop and oversee Build Lists for regulatory submissions, including Investigational New Drug (IND) applications, Master Files (MFs), and New Drug Applications (NDAs).
- Ensure compliance with FDA Electronic Common Technical Document (eCTD) submission standards, troubleshooting validation errors to ensure successful submissions.
- Collaborate cross-functionally with medical writers, regulatory affairs teams, and project managers to meet submission deadlines and maintain document accuracy.
- Maintain up-to-date knowledge of evolving regulatory requirements, including FDA guidance, to ensure adherence to industry best practices.
Regulatory Operations Associate
Technical Resources International
08.2021 - 10.2022
- Prepared, compiled and published regulatory eCTD submissions based on client's requirements
- Prepared and formatted regulatory documentation for electronic submission to FDA via Electronic Submissions Gateway (ESG)
- Maintained working knowledge of regulatory submission publishing software (Linquent and Lorenz)
- Drafted templates, SOPs, and work instructions for publishing tools to promote efficiency
- Stored, managed, and tracked regulatory documentation via document management system
- Maintained effective high-profile communications and interactions with colleagues, collaborators, and clients as appropriate
- Maintained working knowledge of eCTD submission standards and specifications
- Processed PDF documents using publishing plug-ins (Smartdesk and ISI toolbox)
- Troubleshoot smartdesk issues and validation errors to provide the most efficient solutions
- Provided other administrative and regulatory support as assigned
- Trained new employees in eCTD compliance, publishing, and electronic Submission to FDA through ESG
Research Associate
The George Washington University/ Cervical Cancer Study
01.2021 - 05.2022
- Developed strategies to improve study recruitment during the COVID-19 pandemic
- Conducted recruitment activities for an HPV self-sampling and cervical cancer study
- Performed data analysis using SPSS and NVIVO statistical software
- Developed and implemented social media strategies to improve recruitment efforts
- Prepared and reviewed documentation for submission to IRB
Research Associate
Fox Chase Cancer Center
08.2018 - 07.2019
- Conducted a meta-analysis for a study on Prostate Cancer in Males of African Ancestry
- Prepared IRB Submissions
- Organized community outreach programs to improve recruitment retention for Prostate Cancer screening
- Developed laboratory safety protocols for DNA extractions
- Performed DNA extractions from specimens collected from subjects
Education
Master of Public Health - Global Health Epidemiology and Disease Control
George Washington University
05.2021
B.S - Biology, Chemistry
University of Pittsburgh
04.2018
Skills
- Good Clinical Practice (GCP)
- Pre-IND, INDs and NDAs
- IND Safety Report
- Regulatory submissions
- ISI toolbox
- Linquent
- Linquent Validator
- Lorenz
- Trial master file
- Electronic submission to FDA via FDA Gateway
- Adobe Acrobat
Certification
Project Management Professional (PMP)
Professional Development
- The Protection of Human Research Subjects - Good Clinical Practice, Collaborative Institutional Training Initiative (CITI) Program
- Good Manufacturing Practice (GMP) Introductory Training
- Medical Device Regulation 2017-745 EU Regulatory Affairs
- Practical Regulatory Affairs 2020 - US FDA Medical Devices
Research
- Master's Thesis, Understanding Barriers of Cervical Cancer Screening in Rural Southwest Nigeria, Osun State. Focusing on Religion, Education and Cultural Factor, 01/01/21, 05/01/21, Conducted a systematic review of Cervical Cancer Screening Knowledge in Rural Nigeria, Reviewed cervical cancer screening literature at the local, national, and international level, Proposed a program which was implemented to improve the quality of cervical cancer knowledge and screening in rural Nigeria
- Epidemiologic Methods for Data Analysis, 01/01/20, 06/01/21, Analyzed quantitative data of a cervical cancer study using SAS and SPSS, Transcribed qualitative public health data using NVIVO software to examine the impact of community partnership on the health outcomes of low-resource communities.
- Literature Review Participation, 01/01/20, 06/01/21, Exposed to study design and preparation of manuscript on lessons learned in the recruitment and retention of Women Living with HIV, Learned about different viruses, infectious diseases, and transmission cycles during the first phase of Manuscript preparation
- Translation Neuroscience program, 10/01/16, 01/01/18, Altered glutamate co-expression network Topology linked to spine loss in the auditory cortex of schizophrenia., Conducted data analysis using Skyline To integrate protein synapse, Performed laboratory maintenance on equipment and supply stock
Timeline
Regulatory Submissions Specialist
General Dynamics Information Technology (GDIT)
10.2022 - Current
Regulatory Operations Associate
Technical Resources International
08.2021 - 10.2022
Research Associate
The George Washington University/ Cervical Cancer Study
01.2021 - 05.2022
Research Associate
Fox Chase Cancer Center
08.2018 - 07.2019
Master of Public Health - Global Health Epidemiology and Disease Control
George Washington University
B.S - Biology, Chemistry
University of Pittsburgh
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