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 Job #03170 Email this job to a friend
About our client
Our client is the country’s oldest family owned private label health and beauty care company. It serves retailers in all states across the USA. They have produced and manufactured their own private label beauty products for the last 90 years, as well as distributing branded products. The company has marketed products, an experienced management team and an empowering corporate culture that is focused on the professional development of its employees. This is a great opportunity for the right candidate.
Position Location
Regulatory Affairs Supervisor St. Louis, Michigan
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Exhibit team player qualities of cooperation and coordination
2) Ensure professional interaction in all business contacts, all day, every day
3) Be present for work when scheduled
4) Comply with all company safety rules, procedures and guidelines
5) Provide leadership and strategic decision-making
6) Develop professional relationships within the company with other technical departments and managers
7) Monitor and interpret the federal register CFR, ATF and other sources that provide information on new laws about the food, drugs and cosmetics industry
8) Advise and inform management on state and federal regulations
9) Review and approve proposed label and trade dress copy for compliance
10) Ensure compliance with FDA and Fair Packaging and Labeling Act
11) Draft and submit monthly reports to ATF for alcohol and denatured alcohol processing and storage
12) Register annually with the FDA as a drug manufacturer and list all products that fall into a drug category
13) Check documents for compliance with state and federal laws and verify their accuracy
14) Ensure regulatory compliance by helping develop comprehensive internal and external audit programs
15) Acquire information on current and applicable regulations by reading trade journals, state correspondence and the federal register as well as distribute this information to plant staff
16) Review patent and trademarks available from Patent Trademark Office as well as infringement on competitors or name brand equivalent products
Requirements
1) Bachelor's Degree (Science preferred)
2) Minimum 3 years of experience in regulatory affairs in the drug and cosmetic industry with 3 years in a supervisory role
3) Practical experience in the FDA inspection procedures
4) Familiarity with federal register, technical regulator notes, cosmetic ingredient review, CFR and the FDA enforcement manual
5) Understanding of machines, tools, equipment and work aids
6) Excellent negotiation and communication (written and oral) skills
7) Ability to manage several projects simultaneously and coordinate with large numbers of business contacts
8) Ability to operate computers and all related programs including the Internet and other standard office equipment
9) Self-directed and motivated

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