Welcome To CarrollCLEAN - Applying For The Regulatory Affairs Associate Position

This position is responsible for regulatory submissions to the FDA, state and federal EPA, Health Canada, OSHA, and certifying agencies, as necessary. This position will maintain all aspects of regulatory and labeling functions for existing and new products; including review and approval of site licensing requirements; compliance with permitting and licensing requirements; responses to inquiries from regulatory authorities. This position will prepare all Material Safety Data Sheets, process Trademark requests for new products, and be the trainer for DOT and GHS.

Responsibility:

• Manage registrations with Federal and State EPA agencies for new and existing products. This includes:
• Identification of required submission elements
• Identification of timelines and costs
• Ensures the proper data is developed
• Develops accurate submission containing all required elements
• Key contact with EPA and FDA and other regulatory agencies. Responsible for tracking and monitoring the process of submissions
• Develop and maintain an in-depth, on-going knowledge of EPA pesticide regulations (FIFRA) and requirements for submission of registration applications and required label changes.
• Submit Toxic Release Inventory reports (TRI’s).
• File necessary paperwork to FDA for renewal of establishment and NDC numbers.
• File products with the FDA.
• Prepare documentation and submissions for certifying agencies such as NSF/DfE and Ecologo.
• Recertify DOT regulated packages every two years.
• Yearly notification to California Air Resources Board (CARB).
• Originate pesticide registration SOPs, guidelines, policies and templates to streamline and facilitate rapid regulatory responses to new product and new market initiatives.
• Maintain well organized and complete files and records for each product including labels, label change history, and MSDS’s.
• Develop and manage Material Safety Data Sheets for our products by ensuring compliance through periodic reviews and maintain current and archived files.
• Submit the company’s state registrations renewals and new registrations.
• Provide oversight and expertise relative to the handling, storage, and shipping of hazardous materials.
• Ensure compliance of DOT and FAA regulations related to the packaging and shipping of hazardous materials.

Essential Qualifications:

• Associate degree (prefer in a Scientific)
• Demonstrated Regulatory Affairs experience in a regulated industry
• Experience with EPA Antimicrobial Pesticide applications a plus
• Extensive knowledge of global cosmetic and cosmetic/drug product regulations including The Food
• Drug and Cosmetic Act (FD&C) and The Fair Packaging and Labeling Act (FPLA)
• Demonstrated proficiency in the use of computers and Microsoft Office 365

Work Environment:

Office Work Environment with some walking throughout the manufacturing areas of the facility