Regulatory Affairs Supervisor

Enhance your career by putting your valuable experience to work in a great team environment while contributing to the success of major biotech, pharmaceutical and medical device companies.

 

Compliance Team, Inc. offers exciting opportunities for top-notch professionals with strong biotech, pharmaceutical and/or medical device industry experience. Our client-company, located in the St. Louis area, is currently seeking talented, highly-motivated individuals for the full-time permanent position described below.

 

The Regulatory Affairs Supervisor ensures and assists with compliance of government regulations; advise, instruct and recommend policies to ensure compliance. Monitors regulatory publications and reports on changes, oversees the daily operations of the Regulatory Affairs Dept.

 

The Regulatory Affairs Supervisor responsibilities include:

·  Provides leadership and strategic decision making

·  Monitor and interpret Federal Register CFR, ATF, and other sources that provide information on new laws about the Food, Drugs and Cosmetics industries

·  Review and approve proposed label and trade dress copy for compliance; insure compliance with FDA and Fair Packaging and Labeling Act

·  Draft and submit monthly reports to ATF for alcohol and denatured alcohol processing and storage

·  Register annually with the FDA as a drug manufacturer; list all products that fall into a drug category

·  Check documents for compliance with state and federal law; verify accuracy

·  Ensures regulatory compliance by helping develop comprehensive internal and external audit programs

·  Acquires information on current and applicable regulations by reading trade journals and state correspondence, and the Federal Register; distributes information to plant staff

·  Review patent and trademarks available from Patent Trademark Office infringement on competitors or name brand equivalent products

 

Requirements:

In addition to the responsibilities stated above, the position requires the following skills and experience:Bachelor's Degree preferably in SciencesMinimum of 3 years in Regulatory Affairs in the drug and cosmetic industry, with 3 years in a supervisory roleAbility to manage several projects simultaneously and coordinates with large numbers of business contactsExcellent written and oral communication and negotiation skills required.  Self-direction and motivation requiredFirst hand experience with the FDA inspection procedures

 

 

 

Compliance Team, Inc. provides validation services, compliance consulting services, and technical staffing services as a solution to support our pharmaceutical, biotech, and medical device clients permanent and temporary technical staffing needs. Please visit our web site at www.complianceteaminc.com.

 

Employer Information:

 

The client-company associated with this position will not receive your resume or be notified of your interest in this position without your prior approval. Please forward any inquiries or questions regarding this opportunity to jobs@complianceteaminc.com .

 

Contact Information:

For consideration, please send an MS Word copy of your resume via email indicating the position of interest to jobs@complianceteaminc.com .