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Regulatory Affairs Specialist

Company Name:
ALKU
Environment:
Our client is a large medical device and pharmaceutical manufacturer. This project is located at the Customer Channels Group (CCG) which focuses on Distribution. Our client will need a Regulatory Affairs Specialist to come in and provide overall Regulatory Affairs support, primarily focused on classification of Medical Devices, Regulatory permits and licensing, and Regulatory oversight of alcohol distribution.

Principle Duties and Responsibilities:
The consultant will be working to support our client's regulatory activities as they relate to their products. They will have a strong regulatory background as it relates to classification of medical devices and pharmaceuticals and will be responsible for the following:

Advise the Director of RA on upcoming product issues and recommend response strategy
Remain abreast of developing trends in domestic product regulations.
Recommend action to address trends, including influence of regulations, in consideration of CCG business strategies.
Pursue cost reductions consistent with regulatory compliance and prudent product regulatory risk management.
Serve as sponsor for major regulatory software developments (e.g. Customer License System, Regulated product data base, etc.) and Practical Process Improvement (PPI) teams (e.g., regulatory process review).
Responsible for international and domestic wholesale distribution licenses, permits, product registrations, and FDA product labeling claims.
Assure transaction compliance with regulations concerning: Rx Drug & Medical Devices, DEA controlled substances; Over the Counter (OTC) drugs; Florida Ether sales and cGMP standards:
Serve in the sub-administrator role for Master Control.
Assure that Master Data is properly control coded for Rx products, medical devices, Alcohols and ethers.

Required:
International & Domestic Regulatory Affairs: 5-8 years
Medical Device & Pharmaceutical
Alcohol & TTB Regulations
NABP (National Association of Boards of Pharmacy) & Verified Accredited Wholesale Distributor (VAWD), State Wholesale Pharmaceutical Licensing, State Board of Pharmacy
Project Management
B.S. in Chemistry, Biology, Toxicology or related science
Database Management: MasterControl, COGNOS reports
Knowledge/experience with FDA, DEA, EPA, TTB and DOT regulations
Knowledge of international regulations as required to support product transactions.

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