Summary
Overview
Work History
Education
Skills
Certification
Pharmaceuticalskills
Personal Information
Affiliations
Languages
Timeline
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MUHAMMAD ALI KAMAL

Mount Prospect,IL

Summary

Seasoned Regulatory Affairs Specialist with a robust background at Zimmer Biomet, showcasing expertise in FDA and EMEA submissions, complemented by a strong foundation in GMPs and GLPs. Demonstrates exceptional analytical and critical thinking abilities, ensuring compliance and driving process improvements. Proven track record in leveraging Adobe Acrobat Pro and MS-Excel to enhance operational efficiency.

Overview

7
7
years of professional experience
1
1
Certification

Work History

Lab Incharge

American Diagnostic Laboratory
Morton Grove, IL
09.2023 - 02.2024
  • Created reports through MS-Excel, MS-Word
  • Handled calls of doctors, patients and customers
  • Created invoices to doctors and patients
  • Entered lab results into computers and maintained them Provided technical support to doctors and worked with an IT team offshore

Regulatory Affairs Specialist

Zimmer Biomet
Warsaw, Indiana
01.2023 - 08.2023
  • Managed IRRs and AdHocs for registration and submission requests across countries
  • Reviewed DHF scopes, archival memos, and product labeling
  • Created and maintained Technical Files/Design Dossiers for CE mark, focusing on MDR project (since May 2021)
  • Assessed Technical File documents, including DoC, Technical Documentation Summary, GSPR Checklist, and Summary Table
  • Evaluated labeling changes in LRF spreadsheets and reviewed GSPR, TD summaries, DoC, CEP, and ZTP
  • Applied critical thinking daily, updated project databases, and supported management in process improvement

Regulatory Affairs Labeling Associate INTERN

Fresenius Kabi
Lake Zurich, IL
02.2022 - 12.2022
  • Proofread vial, tray, carton, and package insert labels
  • Create and update labeling with input from Medical, Product Development, Package Engineering, and Marketing teams
  • Coordinate proofreading of labeling artwork
  • Ensure draft and final labeling meet USP and FDA standards
  • Maintain high-quality, error-free labeling documentation
  • Distribute labeling materials to manufacturing plants, suppliers, and vendors (domestic and international)
  • Create FDA submission labeling in SPL (XML) format
  • Manage electronic files for current and proposed labeling

Regulatory Affairs Associate INTERN

Xttrium Laboratories Inc
Mt Prospect, IL
07.2021 - 11.2021
  • Researched global regulatory submissions using FDA 21 CFR 210/211, 21 CFR 820, and ICH guidelines
  • Submitted ICSRs via Safety Reporting Portal for ADE reporting
  • Compiled annual product reviews for manufacturing metrics
  • Authored validation protocols and reports; experienced in cGMP and GDP
  • Managed time effectively under deadlines with strong attention to detail
  • Proficient in Adobe Acrobat, XML, and Microsoft Office Suite
  • Handled all business licenses, certificates, and permits on-site; created databases to track them
  • Managed FDA 510(k) submissions and approvals for OTC devices; supported regulatory impact assessments for Class II devices
  • Assisted in risk assessment and UDI initiatives, and supported global labeling traceability
  • Prepared technical sections, labeling, and legal documents for registrations and submissions
  • Conducted renewals, amendments, and quality-related documentation, including CAPA, machine validation, complaint trending, supplier evaluations, and FDA/ISO 13485 inspections
  • Coordinated with clinical trial sites for documentation, study material resupply, protocol questions, and database documentation

Manager of Operations

Express Convenience Shop
Oshkosh, WI
08.2017 - 08.2019
  • Managed station operations ensuring superior customer service and operational integrity.
  • Developed schedules ensuring cost compliance and allocated needed resources
  • Oversaw sales, inventory, and staff on a monthly basis. Conducted and performed inspections of all gas station equipment and facilities.
  • Maintained and obtained a clean and customer friendly environment for various customers.
  • Enforced and implemented strict policies and procedures of the gas station.

Education

Associates - Computer Science

Milwaukee Area Technical College
Milwaukee, WI

Skills

  • Adobe Acrobat Pro
  • MS-Excel
  • MS-Word
  • MS-PowerPoint
  • Notepad
  • Notepad
  • MS-Outlook
  • ISI toolbox
  • Familiarity with FDA guidelines
  • Experience with submissions to EMEA and Health Canada
  • Electronic submissions in eCTD format
  • Electronic Submissions Gateway (ESG)
  • USP guidelines
  • Complete understanding of GMPs
  • GLPs
  • GCPs
  • Knowledge of HPLC
  • UV Spectroscopy
  • Gas Chromatography
  • Capillary Electrophoresis
  • Atomic Absorption

Certification

PGDCA in Computers

Pharmaceuticalskills

  • Familiarity with FDA guidelines
  • Experience with submissions to EMEA and Health Canada
  • Electronic submissions in eCTD format and via electronic submissions gateway (ESG)
  • USP guidelines
  • Complete understanding of GMPs, GLPs and GCPs
  • Knowledge of HPLC, UV Spectroscopy, Gas Chromatography, Capillary Electrophoresis, Atomic Absorption

Personal Information

Residency: Permanent Resident

Affiliations

  • Cricket Sport
  • Working Out
  • Travel
  • Volunteer for Humanitarian Aid

Languages

English
Native/ Bilingual
Urdu
Native/ Bilingual
Hindi
Native/ Bilingual
Portuguese
Elementary

Timeline

Lab Incharge

American Diagnostic Laboratory
09.2023 - 02.2024

Regulatory Affairs Specialist

Zimmer Biomet
01.2023 - 08.2023

Regulatory Affairs Labeling Associate INTERN

Fresenius Kabi
02.2022 - 12.2022

Regulatory Affairs Associate INTERN

Xttrium Laboratories Inc
07.2021 - 11.2021

Manager of Operations

Express Convenience Shop
08.2017 - 08.2019

Associates - Computer Science

Milwaukee Area Technical College

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