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regulatory affairs associate

Location:
Aurora, Illinois, United States
Salary:
65000
Posted:
October 30, 2018

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Resume:

MUNIBA ANWAR

**** *********** **, ****** ** ***** - 331-***-****

ac7j0g@r.postjobfree.com

https://www.linkedin.com/in/muniba-anwar-b4010835/

A highly motivated, Bio-engineering professional with 2+ years of research and regulatory experience. A recognized team

player having strong organizational skills, an ability to juggle multiple tasks, critical thinking and communication skills with

an ability to learn complicated issues. Looking for a role in Regulatory/Engineering within a pharmaceutical/Food company.

PASSION FOR EXCELLENCE TEAM WORK EFFICIENCY & PERFORMANCE

SKILL SET:

Six Sigma, Baxedge, SharePoint, OHSA, LabVIEW, MATLAB, Maple, SolidWorks, Testworks, SoftMax Pro, Microsoft Office Suite, OpenSim, 3D CAD, Fluent in English and Urdu/Hindi.

PROFESSIONAL EXPERIENCE

Baxter Round Lake, IL

Regulatory Affairs Associate III Jun 2018 – Present

Data import of product data into Baxedge.

Assist team in eCTD submission.

Assist team in writing domestic drug regulatory submissions in compliance with FDA regulations.

Complete eATF requests on SharePoint sites.

Review of data from the source location.

Communicating with other members about questions on data providing feedback to supervisor after each import.

Maintaining record of the data being imported.

Generate weekly report of overall import status.

Attend meetings with the team to share updates.

Northwestern University Hospital Chicago, IL

QA / Research Coordinator October 2010-December 2010

Achieved OHSA (Occupation Health and Safety) Compliance and Implemented IACUC NON-VA version.

Ensure quality, consistency and accuracy in preparing research finding and sharing them with the team.

Facilitated research using microtome whilst working with rats, and ensured they received proper post procedure.

Did a research study that characterizes the biomechanical responses of the buttock and lower extremity soft tissue to continuous or intermittent mechanical pressure in normal and spinal cord injured patients.

UIC Chicago, IL

Research Associate August 2009-May 2010

Developed a prototype, fabricated a visual stimulus system for Glaucoma diagnosis.

Sketched 3D Solidworks drawings of the project device.

Utilized PCB express software to outline the PCB design, Performed soldering.

Operated Oscilloscope and Function generator to test light Emitting Diode(LED) arrays.

Prepared monthly status reports, presentations, poster outline and Expo exhibition.

Comprehended Good Manufacturing Practice(GMP) guidelines for Medical Device.

Bioengineering and Bioinformation Summer Institute (BBSI) Clemson University, Clemson, SC

Biomedical Intern May 2009 – July 2009

Engage in two consecutive summers of research with Dr Thomas Boland, focused on using inkjet printers to assemble cells and biomaterials into viable and functioning structures.

Participate in workshops regarding different areas of bio-engineering e.g. Histology, Pathology & Microbiology etc.

UIC African American Academic Network Chicago, IL

Tutor September 2008 – August 2009

Tutored undergraduate students studying physics and calculus.

Prepared coursework, and study guides for the duration of study, focusing on individual student needs and weaknesses.

Led peer review groups and workshop sessions.

Mentor

Women in Science and Engineering (WISE) January 2008 – May 2009

Chicago, IL

Tutored female high-school students with current coursework syllabi and ongoing assignments

Mentored, guided, encouraged and prepared the students for their AP Courses.

EDUCATION

Bachelors of Science in Bioengineering

University of Illinois at Chicago (GPA: 3.63 / 4.0) May 2010

PROFESSIONAL CERTIFICATIONS AND TRAININGS

Excel for Data Analysis and Visualization

Microsoft Certified November 2, 2015

Data Analytics for Lean Six Sigma (In progress)

University of Amsterdam. Completion date: Nov 2018

LEADERSHIP DEVELOPMENTS, HONORS & ACTIVITIES

Biomedical Intern

Bioengineering and Bioinformation Summer Institute (BBSI)

Clemson University, Clemson, SC

Vice President of National Engineering Honors Society (Tau Beta Pi)

Chicago, IL

Dean’s List - First Prize – Designing and Fabrication of a Visual Stimulus System for Early Glaucoma Diagnosis

University of Illinois at Chicago

Chicago, IL

REGULATORY AFFAIRS ASSOCIATE, QA ENGINEER & DATA ANALYST



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