Regulatory Affairs Coordinator

Rousselot•Irving, TX

1d•Onsite

About The Position

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.

Requirements

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.
Strong organizational and time management skills.
Ability to work effectively with diverse groups of associates at all levels of the organization and customers.
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.
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.
Knowledge of Database, Internet, Spreadsheet and Word Processing software.
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.
Must be able to remain in a stationary position.
Must be able to move about inside/outside office or work location.
Operates a computer and other office machinery.
Must be able to position one's self to maintain computers in the lab, including under desks and in the server closet.
Must be able to ascend/descend on a ladder.
Must be able to use senses to; effectively communicate with co-workers and clients and detect hazardous conditions.
Up to 10 pounds
Up to 25 pounds
Close vision (clear vision at 20 inches or less)
Distance vision (Clear vision at 20 feet or more)
Peripheral vision
Depth perception

Nice To Haves

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.

Responsibilities

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.
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.
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.