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Nouryon · 4 days ago

Regulatory Specialist

Bridgewater, NJ

Full-time

Onsite

Mid, Senior Level

4+ years exp

Nouryon is a global company focused on creating innovative and sustainable solutions. The Regulatory Specialist will ensure compliance with food contact regulations, manage FDA notifications, and provide regulatory guidance to support business goals.

ChemicalChemical EngineeringManufacturing

Responsibilities

Possess aptitude to breakdown and digest complex regulations and ensure compliance with applicable requirements

Hold strong chemistry knowledge in the Food Contact industry

Solutions oriented mind set with excellent problem-solving skills

Good communication skills with the ability to engage people at all levels of the organization; Ability to resolve conflicts and building organizational alignment

Highly effective with stakeholder management and capability to build strong relationship internally and externally

Proficient with MS Office: Word, Excel, PowerPoint

Lead the regulatory assessment of Food Contact compliance requests

Guide and manage business expectations regarding feasibility of Food Contact Notification requests

Coordinate and lead the data gathering/generation to support an FDA Food Contact Notification

Author, manage, and lead the submission of US FDA Food Contact Notifications

Responsible to address and support customer regulatory requests regarding Food Contact applications

Establish and lead in-house Food Contact Notifications (FCNs) to US FDA

Clearly understands Food Contact regulatory requirements

Support and drive business goals by providing product regulatory advice/guidance and/or management of emerging regulations to the Food Contact Organization

Qualification

Food Contact NotificationsFDA regulations knowledgeChemistry knowledgeStakeholder managementRegulatory complianceProblem-solving skillsBusiness acumenMS Office proficiencyCommunication skillsTeam collaboration

Required

Possess aptitude to breakdown and digest complex regulations and ensure compliance with applicable requirements

Hold strong chemistry knowledge in the Food Contact industry

Solutions oriented mind set with excellent problem-solving skills

Good communication skills with the ability to engage people at all levels of the organization; Ability to resolve conflicts and building organizational alignment

Highly effective with stakeholder management and capability to build strong relationship internally and externally

Proficient with MS Office: Word, Excel, PowerPoint

Lead the regulatory assessment of Food Contact compliance requests

Guide and manage business expectations regarding feasibility of Food Contact Notification requests

Coordinate and lead the data gathering/generation to support an FDA Food Contact Notification

Author, manage, and lead the submission of US FDA Food Contact Notifications

Responsible to address and support customer regulatory requests regarding Food Contact applications

Establish and lead in-house Food Contact Notifications (FCNs) to US FDA

Clearly understands Food Contact regulatory requirements

Support and drive business goals by providing product regulatory advice/guidance and/or management of emerging regulations to the Food Contact Organization

Chemistry or Toxicology PhD 4+ years of relevant experience, or M. Sc in Chemistry or Toxicology or related field and > 6 years of relevant experience

Minimum 4-6 years of experience including direct experience in the following areas:

Experienced in authoring, managing, and submitting Food Contact Notifications to US FDA authorities or relevant work

Expertise or working knowledge of 21CFR Parts 170 thru 189 and FDA GRAS

Experience with Threshold of Regulation determination, Calculation of Cumulative Dietary Intake, and Inventory of Effected Food Contact Substance

Direct experience in supporting complex Food Contact technical queries

Has clear understanding of the regulatory landscape of the Food Contact industry

Business acumen and support by providing product regulatory advice/guidance and/or management of emerging regulations to R&D and M&S organizations