Regulatory Affairs Coordinator

Darling Ingredients Inc.; Irving (TX); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

401(k)

Health insurance

Dental insurance

Vision insurance

Paid time off

Job summary

Rousselot, the Darling Ingredients health brand, seeks a Regulatory Affairs professional to manage regulatory documentation, track regulatory changes, and support the needs of food, food supplements, pharmaceutical, biomedicals and animal by-product customers.

You will maintain supplier compliance for the USA and prepare FDA affidavits, Letters of Guarantee and Prop 65 statements, collaborating with project teams to ensure timely, compliant results.

Qualifications

• Experience in regulatory documentation and compliance.
• Experience with FDA submissions and shipments.
• Ability to maintain USA supplier compliance and regulatory records.

Responsibilities

• Maintains accurate regulatory statements to ensure global compliance.
• Prepares regulatory documents for customers (Letters of Guarantee, Prop 65).
• Prepares FDA shipment affidavits and regulatory submissions.
• Represents regulatory affairs on project teams and provides guidance.
• Communicates progress on regulatory projects and ensures team objectives are met.
• Completes and manages Customer Quality Questionnaires.
• Follows food safety procedures and promotes a strong food safety culture.

Skills

Regulatory affairs

Regulatory documentation

FDA compliance

Team collaboration

Job description

Company Details

Rousselot is the global leader of collagen-based solutions* for the food, health and nutrition, biomedical and pharmaceutical sectors. We convert the full potential of the collagen molecule into solutions that sustain people's health and well-being. Working in partnership with our global customer‑base, we deliver advanced ingredient solutions that enable innovation, excite today's consumers, and contribute to public health. Through our state‑of‑the‑art operations, extensive technical expertise and sustained scientific research, we help our customers achieve their goals, create world‑class products, and we "Reach further together". Rousselot is Darling Ingredients' health brand.

*Collagen, Market estimates and trend analysis, 2022 Grand View Research.

Rousselot offers full time employees a full suite of benefits including but not limited to the following: 401(k), Health, Dental and Vision Insurance, and Paid Time Off.

Job Summary

Manages regulatory documentation and statements, tracks regulatory changes, and maintains customer and regulatory databases. Provide a strong tie to supporting the regulatory needs of food, food supplements, pharmaceutical, biomedicals and animal by-product needs for our customers. Manages and maintains supplier compliance for USA.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

Regulatory

• Maintains accurate regulatory statements to ensure global compliance.
• Prepares various regulatory documents as required by customers (i.e. Letters of Guarantee, Prop 65 Statement, EDQM's, etc.)
• Prepares FDA shipment Affidavits.
• Effectively represents Regulatory Affairs on project teams and provides regulatory guidance as outlined below.
• Reviews documents for regulatory compliance.
• Prepares submissions to regulatory authorities.
• Communicates importance of Regulations and Compliance.
• Represents the company with regulatory agencies.
• Works effectively in a team environment to ensure not only individual tasks are accomplished, but that team and department objectives are achieved.
• Communicates progress on regulatory projects.
• Projects professionalism and a cooperative demeanor.

Quality

• Researches customer inquiries and prepares regulatory/quality statements as necessary.
• Completes and manages Customer Quality Questionnaires.

• Follows all food safety procedures and practices to promote our food safety culture.