Motivated professional with work experience in regulatory affairs, an educational background in biomedical engineering, and
excellent collaborative skills; seeking a role contributing to an innovative biotechnology company where I can continue my
development while making immediate contributions within the field of the life sciences.
Experience working with domestic and international health authority regulations to support Sanofi Pasteur's biologics portfolio via a
series of rotational assignments.
Each rotation lasted a period of 6 months and concluded in a summary presentation to the department.
Using Thomas Reuter's Cortellis regulatory database and health authorities' guidance documents, created a list of
requirements for clinical trial applications to EU member states under the Voluntary Harmonization Procedure.
Completed and authoring and editing of eCTD Module 1 documentation for submissions to update clinical information
in the BLA and IND for Menactra® vaccine including investigator registration, protocols, interim and final reports, and
posting to clinicaltrials.gov.
Contributed to the regulatory strategy for the renewal of Menactra®'s registration in Haiti and it's execution.
Approved finished lots, of Menactra® vaccine, for international release using RIMS (SHARE, RegFAST, & D2) to
ensure adherence to approved international licenses.
Regulatory representative on a cross-functional project team in charge of updating the CCDS for Menactra® vaccine to
align with the Pregnancy and Lactation Labeling Rule (PLLR) issued by FDA.
Assisted in Proofreading activities for labeling documentation for accuracy in French, English, and Spanish.
Represented the company at the VRBPAC for 2016/2017 northern hemisphere influenza strain selection.
Annual labeling update to Fluzone® BLA for the 2016/2017 seasonal labeling.
Included editing changes to the package
insert, primary and secondary containers, and posting to Dailymed.com.
Analyzed internal labeling change control processes for the North American region and identified areas for inter-site
improvements and harmonization.
Chemical Controls and Manufacturing (CMC).
Regulatory lead for annual update of Fluzone® international licenses for the 2017 southern hemisphere influenza season.
Worked cross functionally with multiple departments (e.g.
Quality Control and Stability) to author and edit eCTD
Module 3 documentation required for the submission to 10 countries.
Provided regulatory assessments and quality reviews, as part of the viral CMC team, for multi-site changes to facilities
manufacturing ACAM2000® and IMOJEV® vaccines.
Tracked and summarized weekly team performance, via a lean based visual management system, using Key
Performance Indicators to assess possible areas for individual and team improvement.
04/2015Biomedical Senior Design Course
Worked with four peers to create a biomedical device based on given client specifications.
Used the engineering design process to
develop the product into a proof of concept prototype that would theoretically comply with FDA regulations.
extensive research into the science behind the device and benchmarking against competitor products.
The resulting device and
concept was tested and presented at the Northeast Bioengineering Conference (NEBEC), as well as, the RPI senior biomedical
The presentation was recognized as "Best Presentation" at the senior showcase.
10/2014Biomedical Engineering Laboratory
Worked with two other peers to design and perform our own research experiment on the effects of drill hole size on the ultimate
yield strength of chicken tibia in two-point and three-point bending.
Created a comprehensive protocol and report, in line with the
regulations of an accredited scientific journal, detailing the steps and results of the experiment.
Received an introduction to instruments and procedures for measurement of pressure, flow, bioelectrical potentials,
biomechanical and biomaterial properties, using invasive and noninvasive techniques.
Gained experience working with strain
gauges, spectrophotometers, ImagePro software, ATS mechanical testing machine, signal processing, and statistical data analysis.
Undergraduate Researcher07/2014 － 04/2015RPI
Worked as an undergraduate researcher on an independent project assessing calcium phosphate precipitation on etched bioactive
Created simulated body fluid (SBF) to evaluate precipitation and presented the findings at an undergraduate research
Helped maintain and quantify cell cultures, designed a 3D printed bone holder for micro CT, evaluated bone formation using
ImageJ, created layered photocured dental materials using a photosensitive epoxy and human teeth.
Author and lead editor for a protocol for evaluating the effects of heat shock on MC3T3-E1 cells.
Education and Training
Bachelor of Science:Rensselaer Polytechnic Institute (RPI) - Biomedical Engineering Biomaterials General PsychologyTroy, NY3.5/4.0 Biomedical Engineering Biomaterials General Psychology
Biomaterials Science and Engineering, Biomechanics I, Clinical Orthopaedics and Contemporary Research,
Biomaterial Applications in Medicine, Thermals & Fluids I, Introduction to Cell and Tissue Engineering:
Activities and Honors
Rensselaer Society of Engineers: Vice President Spring 2014-Spring 2015
Duties included: Leading and organizing the executive committee meetings, voting member of the executive committee, enforcing
the penal code and bylaws, acting as leader of the house in absence of the president, and documenting the fine system for a fraternity
consisting of forty-three members.
Bachelor of Science : Rensselaer Polytechnic Institute (RPI) - Biomedical Engineering Biomaterials General Psychology Biomaterials Science and Engineering, Biomechanics I, Clinical Orthopaedics and Contemporary Research,
Biomaterial Applications in Medicine, Thermals & Fluids I, Introduction to Cell and Tissue Engineering :
Create a job alert for [job role title] at [location].