Regulatory Affairs Coordinator

Darling Ingredients; Irving (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

Darling Ingredients in Irving, TX seeks a Regulatory Affairs specialist to manage regulatory documentation, track changes, and support regulatory needs for food, supplements, pharma, biomedicals and animal by-products. You will maintain customer and regulatory databases and prepare regulatory submissions.

Responsibilities include preparing FDA shipment affidavits, Prop 65 statements, EDQM's, and ensuring supplier compliance while working closely with cross-functional teams to meet quality and

Qualifications

• 1 year of regulatory experience, preferably in food/pharma.
• BS degree in Chemistry, Food Science, Quality Management or equivalent.
• Experience with U.S. government agencies such as FDA/USDA/APHIS preferred.

Responsibilities

• Maintain regulatory statements to ensure global compliance.
• Prepare regulatory documents (Letters of Guarantee, Prop 65, EDQM).
• Prepare FDA shipment affidavits.
• Represent Regulatory Affairs on project teams and provide regulatory guidance.
• Manage supplier compliance and conduct supplier inspections.
• Maintain supplier documentation and audit readiness.
• Collaborate with team to meet department objectives.

Skills

Interpersonal skills

Language skills

Mathematical skills

Reasoning ability

Computer skills

Education

Bachelor's degree in Chemistry, Food Science, Quality Management or equivalent

Tools

Database, Internet, Spreadsheet, Word Processing software

Job description

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.
• 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.

The information contained in this job description is intended to describe the essential job functions required of those assigned to this job. It is not intended to be an exhaustive list of all responsibilities, duties, knowledge, skills, and abilities needed to perform the job. Please note that management retains the right to assign or reassign duties and responsibilities to this job at any time. The ability to competently perform all the essential duties of the position, with or without reasonable accommodation, demonstrated commitment to effective customer service delivery, integrity, and the ability to work productively as a member of a team or work group are basic requirements of all positions at Darling Ingredients.

Darling Ingredients 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 visit https://www.eeoc.gov/poster