Regulatory Affairs Coordinator

About the Role

Manages regulatory documentation and statements, tracks regulatory changes, and maintains customer and regulatory databases. Provides support for the regulatory needs of food, food supplements, pharmaceutical, biomedical, and animal by-product sectors for our customers. Manages and maintains supplier compliance for the USA.

Responsibilities

• Maintains accurate regulatory statements to ensure global compliance.
• Prepares various regulatory documents as required by customers (e.g., Letters of Guarantee, Prop 65 Statement, EDQM's).
• Prepares FDA shipment Affidavits.
• 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 achieve individual, team, and department objectives.
• Communicates progress on regulatory projects.
• 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 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 and follows up with suppliers as needed.

Requirements

• A minimum of 1 year of experience in a regulatory environment, preferably in food, pharmaceutical, or pet food/feed.
• A Bachelor of Science degree in Chemistry, Food Science, Quality Management, or equivalent.
• Experience working with U.S. government agencies such as FDA, USDA/APHIS with food, pharma, and/or pet food/animal feed preferred.

Skills

• 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: Knowledge of Database, Internet, Spreadsheet, and Word Processing software.

Physical & Environmental Demands

• 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.
• Must occasionally lift and/or move up to 10 pounds.
• Ability to travel approximately 10% of the time.
• May be exposed to wet/humid conditions, moving mechanical parts, chemicals, outside weather conditions, and an electrical environment.