FDA Regulatory Affairs Principal Specialist

We are Covestro. We are curious. We are courageous. We are colorful. We refine chemical material solutions with game-changing products. Let us empower you to push boundaries. Join us and our 18,000 colleagues now and together we will make the world a brighter place.

The primary responsibility of this role is to ensure Covestro products meet the requirements of North American federal chemical regulations for food packaging, including the Federal Food, Drug and Cosmetic Act. The successful candidate must be fluent in the complexities of food contact evaluation including exemptions and filings. These responsibilities include the interpretation of regulations, implementing compliance strategies to support the sale of new and existing products, as well as implementing procedures to meet U.S. and Canadian recordkeeping requirements. This position supports all seven Covestro business entities.

Major Tasks and Responsibilities:

• Serve as the lead FDA food contact technical expert ensuring Covestro products meet the complex requirements of the U.S. Food, Drug and Cosmetic Act.
• Lead complex evaluations including exemptions such as self-determined GRAS and identification data for Food Contact Notifications.
• Create regulatory language and respond to FDA related technical customer inquiries.
• Lead cross-functional teams as needed to address regulatory compliance issues.
• Manage external support as needed for regulatory evaluations and submissions to US Food and Drug Administration.
• Monitor, analyze, interpret and disseminate ongoing and newly developing rulemaking affecting food contact. Inform relevant Covestro personnel about potential impact of proposed and final regulations published in the Federal Register.
• Evaluate chemical compositions of Covestro products and raw materials and determine status under FDA, TSCA and CEPA regulations for immediate sale or need for registration.
• Support programs to ensure compliance with the complex requirements of the U.S. Toxic Substances Control Act (TSCA), U.S. Food, Drug and Cosmetic Act, and U.S. Controlled Substances Act and other federal regulatory programs within North America.

Basic Qualifications:

• Master's degree in a technical discipline with 4+ years' experience in FDA food contact assessment; OR PhD degree in a technical discipline with 2+ experience in FDA food contact assessment
• Hands on experience conducting advanced food contact evaluations such as GRAS self-determinations.

Preferred Qualifications:

• Experience preparing or filing FDA Food Contact Notifications

Knowledge and Skills:

• Analytical laboratory experience
• Knowledge of polymer chemistry
• Ability to effectively influence and communicate technical material to Covestro customers and employees
• Strong computer skills, including Microsoft Word, Excel, and PowerPoint
• Must have ability to prioritize work while paying attention to detail

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YOUR APPLICATION

Are you as curious, courageous and colorful as we are? If so, we can offer you an exciting career opportunity. We look forward to receiving your application and resume. Become part of our team - apply now!

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