Regulatory Affairs Coordinator
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.
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.