Regulatory Affairs Quality Assurance

. MEHNAZ

United States +1-857-***-**** ******.*@************.*** LinkedIn

EDUCATION

Northeastern University Boston, MA

Master of Science in Regulatory Affairs June 2024 - Present Relevant Coursework: Regulatory Strategy for Product Development & Lifecycle Management, FDA Medical Device Regulation, Quality Management, Risk Management, Medical Device Development, Safety Sciences, Project Management for Regulatory Affairs, Global Regulatory Affairs Practical Application, Cybersecurity and Regulation of Digital Health Technologies, Product Development and Process Validation.

JNTUH University Hyderabad, India

Bachelor of Pharmacy Sept 2019 - Sept 2023

Relevant Coursework: Regulatory Affairs, Pharmaceutical Jurisprudence, Biopharmaceutics, Clinical Pharmacy, Pharmacology, Biotechnology, Quality Assurance, Industrial & Pharmaceutical Engineering, Medicinal Chemistry, Bio-Organic Chemistry & Drug Development

SKILLS

Functional Competencies

Regulatory Compliance & Research: Knowledge of FDA, EMA, and Health Canada regulations, including IND, BLA, and NDA submissions.

CMC Regulatory Affairs: Understanding of Chemistry, Manufacturing, and Controls (CMC) requirements for investigational drug applications.

Regulatory Documentation & Submissions: Experience with regulatory filings, promotional materials, clinical trial documentation, and Form FDA 2253 submissions.

Quality & Risk Management: Familiarity with quality assurance, risk assessment, and compliance frameworks in pharmaceutical and biologic development.

Data Analysis & Reporting: Expertise in literature reviews, regulatory data interpretation, and compliance documentation.

Project Coordination & Cross-Functional Collaboration: Ability to manage multiple regulatory projects and work with R&D, quality, and compliance teams.

Technical Tools

Regulatory Software: ARGUS Safety, MeDRA Browser, Cara Search Engine

Data & Documentation Tools: Microsoft Office Suite (Excel, Word, PowerPoint)

Regulatory Submissions & Databases: eCTD, SPL, and document management systems EXPERIENCE

Regulatory and research Intern Apr 2025- July 2025 MicroWellness Inc. Boston, MA

• Assisted in preparing and submitting 100+ FDA-compliant promotional materials, labeling, and Form FDA 2253 submissions, ensuring 100% adherence to regulatory standards.

• Collaborated with 5+ cross-functional teams to resolve regulatory challenges, ensuring 100% compliance with advertising and promotion guidelines.

• Increased efficiency and accuracy in regulatory submissions by 30%, contributing to 20% faster approval timelines. PROJECTS

• Research and Formulation Scientist

Formulation and Evaluation of Controlled Porosity Osmotic Tablets of Valsartan International Journal of Pharmaceutical Sciences Review and Research (IJPSRR)

• Analytical Chemist and Lead Researcher

Development and Validation of Liquid Chromatography of Tepotinib in Bulk Drug and Tablet Dosage Form International Journal of Pharmaceutical Sciences Review and Research (IJPSRR)

• Method Development Scientist and Principal Investigator Liquid Chromatography Method Development and Validation for the Quantitative Determination of Finerenone in Bulk Drug and Pharmaceutical Formulation

Technix International Journal of Engineering Research (TIJER)

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