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Job #03370

About our client Our client is a leading private label health and beauty care company. 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 Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Exhibit team player qualities of cooperation and coordination 2) Ensure professional interaction with all business contacts on a daily basis 3) Comply with all company safety rules, procedures and guidelines 4) Provide leadership and make strategic decisions 5) Develop professional relationships within the company with other technical departments and managers 6) Monitor and interpret the federal register CFR, ATF and other sources that provide information on new laws about the food, drugs and cosmetics industry 7) Advise and inform management on state and federal regulations 8) Review/approve proposed label and trade dress copy for compliance 9) Ensure compliance with FDA as well as Fair Packaging and Labeling Act 10) Draft/submit monthly reports to ATF for alcohol and denatured alcohol processing as well as storage 11) Register annually with the FDA as a drug manufacturer and list all products that fall into a drug category 12) Check documents for compliance with state/federal laws and verify their accuracy 13) Ensure regulatory compliance by helping develop comprehensive internal and external audit programs 14) Acquire information on current/applicable regulations by reading trade journals, state correspondence and the federal register as well as distribute this information to the plant staff 15) Review patent and trademarks available from the 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 individual