FDA Regulatory Affairs Principal Specialist jobs in United States
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Covestro · 6 hours ago

FDA Regulatory Affairs Principal Specialist

positionPittsburgh, PA
timeFull-time
remoteOnsite
senioritySenior Level, Lead/Staff
date4+ years exp

Covestro is a company that refines chemical material solutions with innovative products. They are seeking an FDA Regulatory Affairs Principal Specialist to ensure compliance with North American federal regulations for food packaging, focusing on the Food, Drug, and Cosmetic Act.

Advanced MaterialsIndustrialManufacturing

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

Qualification

FDA food contact assessmentFood Contact NotificationsPolymer chemistryAnalytical laboratory experienceComputer skillsEffective communicationAttention to detail

Required

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
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

Preferred

Experience preparing or filing FDA Food Contact Notifications

Company

Covestro

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Glassdoor3.9
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Covestro produces polymer materials that support sustainability in multiple industries.
dateFounded in 2015
location
Leverkusen, Nordrhein-Westfalen, DEU
people-size10001+ employees
web-link
https://www.covestro.com

Funding

Current Stage
Public Company
Total Funding
$2.53B
Key Investors
XRG
2025-11-21Post Ipo Equity· $1.35B
2024-10-01Acquired
2017-09-29Post Ipo Secondary· $1.18B

Leadership Team

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Markus Steilemann
Chairman of the Board of Management, Chief Executive Officer
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Christian Baier
Group CFO
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Recent News

Med-Tech Insights
New film from Covestro unlocks medical device capabilities
2026-01-23
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Covestro delivers new solution for in-home electronic stethoscope
2026-01-22
Energy-Storage.News
Rondo Energy, Covestro break ground on 100MWh thermal energy storage site in Germany
2026-01-21
Company data provided by crunchbase