Nadiyah A. McCarroll

*** ******* ******, *** * . Brooklyn, New York . 11216. 917-***-**** .

acf6hl@r.postjobfree.com

Professional Summary

Senior Regulatory Professional with a proven ability to reduce company cost

and increase overall productivity; interfaces with all levels of business

personnel and regulatory agencies with a proven ability to meet company and

regulatory time lines; excellent leadership, time management, communication

and organizational skills; with the ability to work independently as well

as in a team environment.

Professional Qualifications

. Over 12 years experience working with physicians and other medical

personnel

. Strong familiarity with medical terminology

. Quality Control Pharmaceutical Experience

. Chemical Regulatory and Hazard communication Experience

Professional Experience

July 2012-April 2013 Senior Commercial Regulatory Services

Associate

Allendale, NJ Lonza America Inc.

Microbial Control; Regulatory Services Department

. Reviewed and approved study reports, product

brochures and marketing presentations to insure

accuracy and compliance

. Provided regulatory consultation and guidance for

global projects

. Rsponsible for North America; US, California and

Canadian product registrations and submission

. Regulatory lead for Oil & Gas, Materials

Protection and Hygiene & Preservation Business

March 2008-June 2012 Senior Regulatory Specialist-Biocides

Wayne, NJ International Specialty Products; Product

Stewardship Department

. Initiated regulatory review process for new

product launches; including product registrations;

Safety Data Sheet (SDS) creation; new label

production; review of product brochures, Technical

Data Sheets (TDS), confidentiality agreements and

distributor subregistration agreements

. Responsible for monitoring GLP studies in regards

to toxicology and chemistry testing in according

to OECD and OPPTS guidelines.

. Reviewed toxicological data and assessed hazardous

chemicals and/or chemical components for human

risk exposure and responsible for the submittal of

efficacy data to governmental Agencies in support

of product registrations

. Implement regulatory program database software to

increase efficiency, reduce time and reduce costs

by over 30 percent.

. Provide regulatory leadership and support for the

U.S and global marketing business objectives.

December 2007-March 2008 Clinical Research Coordinator (Volunteer)

Staten Island, NY Staten Island University Hospital; Emergency

Department

. Interviewed patients, obtained informed consent

and reviewed case report forms

. Reviewed study protocols and assisted Nurses and

Physicians with appropriate after care for

patients

. Knowledge of adverse event reporting to health

authorities and case study analysis

(continued)

June 2006-March 2008 QC Scientist I

Pearl River, NY Wyeth Pharmaceuticals/Wyeth Vaccines

Quality Control Microbiology and Environmental

Services

. Performed biological assays on raw materials,

intermediates and finished products

. Analyzed, interpret data and investigated Out of

Specification (OOS) results

. Authored and reviewed SOP's and protocols

. Prepared and monitored quarterly trend reports

. Responsible for monitoring GMP critical laboratory

equipment

. Conducted audits and assisted in the validation of

laboratory equipment

April 1998-November 2011 Clerk/Registrar

Staten Island, NY Staten Island University Hospital; Emergency

Department

. Responsible for retrieving permanent patient

information including medical history, test

results and updating information via internal

database

. Reviewed positive patient laboratory test results

and assist physicians in patient call backs

. Registered patients upon admission into the

emergency department

. Verify and code patient health insurance

information

. Accurately and consistently processed physician

orders and arranged for appropriate medical test

and procedures

. Gained strong familiarity with medical terminology

Computer Skills

. Microsoft Office Applications, Internet, Mac;

LIMS; and regulatory databases; WERCS,

Chemadvisor, JBA and KPRS

Education

May 2004 Wagner College, Staten Island, New York

. Masters of Science Microbiology

January 2002 Brooklyn College (CUNY), Brooklyn, New York

. Bachelors of Science Biology

2

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