Natalie Draus

Background

About Natalie Draus

I work at Sanofi in North America Corporate Compliance/Trade Compliance and my responsibilities include ensuring that Sanofi products and related services meet the requirements of our consumers, and are in full compliance with Good Manufacturing Practices and other Health-regulated requirements (FDA, Border Protection /Customs, & USDA). I'm responsible for importation of all Sanofi drugs, biologics, and medical devices which also include Compassionate Use Shipments. I have interactions with FDA, USDA, CBP, Customs Brokers, Logistics and other import support teams as needed. I liaise with FDA and USDA to provide information and documentation necessary for the release of our imported products under FDA and USDA review. As the U.S. Agent for Sanofi my responsibilities are assisting FDA in communications with our foreign establishments, responding to questions concerning the foreign establishment's drug products that are imported or offered for import into the United States, assisting FDA in scheduling inspections of the foreign establishment. While at Wyeth I wrote new and updated existing Product, Raw Material and General Method monographs following the United States Pharmacopeia – National Formulary (USP-NF) and European Pharmacopoeia (Ph. Eur.) ensuring accurate, complete, and timely issuance of testing procedures. Conducted Manufacturing Investigations (MIRs) and Laboratory Investigations (LIRs). Performed vendor qualification and certifying only those vendors who properly documented the source of animal-derived material to minimize the risk of BSE/TSE (Mad Cow Disease). Pfizer logo Pfizer, formerly known as Wyeth Pfizer, formerly known as Wyeth 21 yrs 6 mos21 yrs 6 mos Pearl River, NY Pearl River, NY QA Laboratory Compliance Specialist Sr. Technical Writer QA Laboratory Compliance Specialist Sr. Technical Writer Jan 1985 - Jun 2006 · 21 yrs 6 mos Jan 1985 - Jun 2006 · 21 yrs 6 mos