Regulatory Affairs Coordinator

Rousselot; Irving (TX); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

401(k)

Health insurance

Dental insurance

Vision insurance

Paid time off

Job summary

Rousselot, a Darling Ingredients health brand, seeks a Regulatory/Quality professional to manage regulatory documentation and supplier compliance. You will track regulatory changes and maintain databases to support food, supplement, pharmaceutical, and biomedical needs for our customers.

Responsibilities include preparing regulatory submissions, coordinating with regulatory agencies, and ensuring compliance across supplier networks.

Qualifications

• A minimum of 1 year experience in a regulatory environment, preferably food, pharmaceutical, pet food/feed.
• A Bachelor of Science degree in Chemistry, Food Science, Quality Management or equivalent required.
• Experience working with U.S. government agencies such as FDA, USDA/APHIS with food, pharma and/or pet food/animal feed preferred.

Responsibilities

• Manages regulatory documentation and statements, tracks regulatory changes, and maintains customer and regulatory databases.
• Provides regulatory guidance on projects and represents the company with regulatory agencies.
• Maintains supplier compliance and participates in supplier audits as needed.
• Ensures global regulatory compliance and prepares FDA shipment affidavits.

Skills

Regulatory

Quality

Documentation

Education

BS in Chemistry or Food Science or Quality Management

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.

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

include the following. 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.
• Maintains Supplier Approval Program and ensures raw material suppliers meet audit standards.
• Performs onsite inspections of suppliers to ensure compliance, when required.
• Manages all required Supplier documentation, follows up with suppliers as needed.

Minimum Qualifications

Education and/or Experience:

• A minimum of 1 year experience in a regulatory environment, preferably food, pharmaceutical, pet food/feed.
• A Bachelor of Science degree in Chemistry, Food Science, Quality Management or equivalent required.
• Experience working with any of the U.S. government agencies such as FDA, USDA/APHIS with food, pharma and/or pet food/animal feed preferred.

Preferred Qualifications

Interpersonal Skills: Strong organizational and time management skills. Ability to work effectively with diverse groups of associates at all levels of the organization and customers.

Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions. Strong communication skills, both oral and written, including attention to detail.

Mathematical Skills: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Computer Skills: To perform this job successfully, an individual should have knowledge of Database, Internet, Spreadsheet and Word Processing software.

Physical & Environmental Demands

Employee is occasionally required to stand, walk, use hands to handle, or feel; reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 10 pounds. Ability to travel approximately 10% of the time. Employee may be exposed to wet/humid conditions, moving mechanical parts, chemicals, outside weather conditions, and an electrical environment.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Rousselot is an equal opportunity employer and gives consideration to qualified applicants without regard to race, color, creed, religion, age, pregnancy, sex, sexual orientation, gender identity, national origin, genetic information, physical or mental disability, military service, protected veteran status, or any other characteristic protected by applicable federal, state and local law. Know Your Rights: If you would like more information, please click on the link and paste into your browser: https://www.eeoc.gov/poster

Working Conditions and Physical Demands

The physical demands and work environment factors described below are representative of those that must be met by an employee to successfully perform the main duties of this job.

Working Environment

None

Occasionally = up to 20%

Frequently = 21% to 50%

Constantly = at least 51%

Exposed to unpleasant or disagreeable physical environments such as high noise level, strong odors, and/or exposure to heat and cold

Exposed to bio hazardous conditions

Exposed to toxic or caustic chemicals which mandate attention to safety considerations

Exposed to Electrical hazards; risk of electrical shock

Handles or works with potentially dangerous equipment

Travels to offsite locations

Other (please Describe)

None

Physical Demands

None

Occasionally = up to 20%

Frequently = 21% to 50%

Constantly = at least 51%

Sit:

Must be able to remain in a stationary position.

Walk

Must be able to move about inside/outside office or work location.

Use hands to finger, handle or feel

Operates a computer and other office machinery.

Stoop, kneel, crouch, or crawl

Must be able to position one's self to maintain computers in the lab, including under desks and in the server closet.

Climb or balance

Must be able to ascend/descend on a ladder.

Talk, hear, taste, smell

Must be able to use senses to; effectively communicate with co-workers and clients and detect hazardous conditions.

Weight and Force Demands

None

Occasionally = up to 20%

Frequently = 21% to 50%

Constantly = at least 51%

Up to 10 pounds

Up to 25 pounds

Up to 50 pounds

Up to 100 pounds

More than 100 pounds

Vision Demands

No special vision requirements

Close vision (clear vision at 20 inches or less)

Distance vision (Clear vision at 20 feet or more)

Color vision (ability to identify and distinguish colors)

Peripheral vision

Depth perception

Ability to adjust focus