Regulatory Affairs Quality Assurance

Ruman Fathima

Stamford, CT ***** ****************@*****.***

203-***-**** https://www.linkedin.com/in/ruman-fathima-276433190/

Education

Sacred Heart University, College of Health Professions, Fairfield, CT Master of Science in Healthcare Informatics, January 2024

•Coursework: Healthcare Operations, Electronic Medical Records, Info Analysis & System Design, Workflow Design & Reengineering, Project Management, Clinical & Bus. Intelligence.

Global Institute of Regulatory Affairs, Pune, India

Postgraduate Diploma in Regulatory Affairs, April 2022

•Coursework: Regulatory compliance, pharmaceutical law, medical device regulations, Quality Assurance, Clinical Trials Management, Post-Market Surveillance, Regulatory Submissions

Rajiv Gandhi University, Bangalore, India Bachelor of Pharmacy, June 2019

•Coursework: Pharmacology, Pharmaceutical Chemistry, Pharmaceutics, Pharmacokinetics, Pharmacodynamics, Pharmaceutical Analysis, Acquiring a Comprehensive Understanding of Drug

Mechanisms, Formulation, Dosage Forms, Therapeutic Uses, Pharmaceutical Sciences

Technical Skills

MS Office Suite, EHR systems, Tableau, Veeva Vault, EXTEDO eCTD manager, ESG Gateway, Adobe Sign, DocuSign, Calyx, SharePoint, Lorenz DocuBridge, Global Submit Validate, ISI Toolbox

Work Experience

PAREXEL, Bangalore, India

Regulatory Affairs Associate, March 2020-November 2023

•Experienced in preparing, compiling, and validating regulatory submissions (paper/electronic) per FDA and regional standards.

•Works closely with internal teams to ensure regulatory requirements are met and submission components are formatted correctly.

•Skilled in publishing, quality control, and validation of submission documents; proficient in MS Word and Adobe Acrobat.

•Assists in developing regulatory guidelines, optimizing submission workflows, and assessing new departmental technologies.

•Mentors junior staff, ensures regulatory compliance, and supports electronic submission transitions.

Accomplishments at Sacred Heart University

•Student Ambassador for HIMSS 2025

•Graduate Assistant for Information Technology

•Student Worker for Information technology

•Graduate Assistant for International Admissions

•Medical Informatics Club President

Language Skills

Fluent in English, Hindi, Telugu, Urdu.

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