Regulatory Affairs Coordinator

The Regulatory Affairs Coordinator is responsible for 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. Coordinates 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:
  1. Reviews documents for regulatory compliance.
  2. Prepares submissions to regulatory authorities.
  3. Communicates importance of Regulations and Compliance.
  4. Represents the company with regulatory agencies.
  5. Works effectively in a team environment to ensure not only individual tasks are accomplished, but that team and department objectives are achieved.
  6. Communicates progress on regulatory projects.
  7. 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

• Bachelor's degree in Chemistry, Food Science, Quality Management or related field, or equivalent relevant experience.
• Minimum of 1 year of experience in a regulatory environment, preferably within food, pharmaceutical, pet food, or animal feed.
• Strong organizational and time-management skills with attention to detail.
• Strong verbal and written communication skills with the ability to interpret technical procedures and government regulations.
• Proficiency with Microsoft Office suite.

Preferred Qualifications

• Experience working with regulatory agencies such as FDA, USDA, and/or APHIS within food, pharmaceutical, pet food, or animal feed environments.

Working Conditions and Physical Demands

• Occasionally exposed to wet/humid conditions, outside weather, chemicals, electrical hazards, and moving mechanical equipment.
• Occasionally requires standing, walking, reaching, climbing, or balancing, stooping, kneeling, crouching, and crawling.
• Must be able to communicate effectively and use applicable senses as required to perform the job.
• Requires the ability to occasionally lift and/or move up to 10lbs.
• Requires occasional travel to off-site locations, approximately 10%.