Senior Regulatory Affairs Specialist

Posted 13 Days Ago
Be an Early Applicant
Irving, TX, USA
In-Office
Senior level
Food • Greentech • Other
The Role
Manages regulatory affairs for food, pharmaceutical, health, nutrition, and animal-feed products. Serves as liaison with FDA, USDA, and import authorities; prepares regulatory submissions, affidavits, customer compliance documents, and technical dossiers; guides R&D and quality teams on global statutory, labeling, claims, import/export, Kosher, and Halal requirements. The role works autonomously on complex files, supports regulatory project teams, and travels approximately 10% of the time.
Summary Generated by Built In

Essential Duties/Responsibilities

Regulatory:

  • Primary liaison with regulatory agencies (USDA, FDA) and Importer of Record for USA.
  • Works autonomously on complex regulatory files and on own specialized projects.
  • Knowledgeable in the requirements for placing innovative products on the market, such as dietary ingredients and food and feed additives, as well as labeling (including structure-function claims, the related scientific supporting evidence, and product formulation) and advertising.
  • Prepares various regulatory documents as required by customers (i.e. Letters of Guarantee, Prop 65 Statement, EDQM’s, etc.)
  • Prepares FDA/USDA shipment Affidavits. 
  • Strong understanding of CFIA regulations and imports/exports.
  • Understanding and guidance of Kosher and Halal certifications and regulations.
  • Manages technical files/dossiers and guides cross-functional R&D and quality teams to meet all global statutory requirements.
  • Proactively navigates import/export requirements for all applicable products.
  • Maintains accurate regulatory statements to ensure global compliance. 
  • 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.
  • Ability to travel up to 20% domestic, occasional international

 

Minimum Qualifications

Education and/or Experience:

  • A minimum of 3 years of experience in a regulatory environment, preferably food, pharmaceutical, health and nutrition, pet food/feed. 
  • A Bachelor’s degree in Chemistry, Food Science, Regulatory Affairs 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:

  • A Master’s degree in Chemistry, Food Science, law or equivalent preferred.

 

Additional Skills and Physical Demands

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.

About UsWe’re one of the world’s leading practitioners of circularity, transforming materials from the animal agriculture and food industries into valuable ingredients. Ingredients that nourish people, feed animals and crops, and fuel the world with renewable energy. About the TeamDarling 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 click on the link and paste into your browser: https://www.eeoc.gov/poster of this job.

Skills Required

  • Bachelor of Science degree in Chemistry, Food Science, Regulatory Affairs, or an equivalent field
  • At least 3 years of experience in a regulatory environment
  • Strong understanding of CFIA regulations and import/export requirements
  • Knowledge of product labeling and claims compliance
  • Understanding of Kosher and Halal certifications and regulations
  • Experience working with FDA, USDA, or APHIS on food, pharmaceutical, pet food, or animal-feed products
  • Master's degree
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The Company
HQ: Belm
10,001 Employees
Year Founded: 1882

What We Do

In a transitioning world, many things change. Global population growth, climate change, increased life expectancy and wealth have put pressure on our natural resources providing us with food, feed, fuel and general well-being. Now, more than ever we need to find viable ways to provide for our changing needs and those of future generations. That’s where we come in. With over 200 processing plants on five continents and sales and distribution offices throughout the world, Darling Ingredients serves the agri-food industry and reduce food waste by collecting and repurposing animal-based co-products and other natural materials that would otherwise be discarded. We convert these into unique and valuable ingredients that fit market demands. This way we connect global supply and demand and contribute to a circular economy.

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