Regulatory Affairs Coordinator

Rousselot is the global leader of collagen-based solutions for the food, health and nutrition, biomedical and pharmaceutical sectors. We convert the full potential of the collagen molecule into solutions that sustain people's health and well-being. Working in partnership with our global customer-base, we deliver advanced ingredient solutions that enable innovation, excite today's consumers, and contribute to public health.

Responsibilities

• Manages regulatory documentation and statements, tracks regulatory changes, and maintains customer and regulatory databases.
• Provides regulatory support for food, food supplements, pharmaceutical, biomedicals, and animal by-product needs.
• Maintains accurate regulatory statements to ensure global compliance.
• Prepares 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, including:
  • Reviews documents for regulatory compliance.
  • Prepares submissions to regulatory authorities.
  • Communicates the importance of Regulations and Compliance.
  • Represents the company with regulatory agencies.
• Works effectively in a team environment to achieve 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 in food, pharma, and/or pet food/animal feed (preferred).

Skills

• 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.
• 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.
• Knowledge of database, internet, spreadsheet, and word processing software.

Benefits

• 401(k)
• Health Insurance
• Dental Insurance
• Vision Insurance
• Paid Time Off

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.
• Lift and/or move up to 10 pounds (occasionally up to 50 pounds).
• 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.
• Unpleasant or disagreeable physical environments such as high noise levels, strong odors, and/or exposure to heat and cold (occasionally).
• Biohazardous conditions (occasionally).
• Toxic or caustic chemicals which mandate attention to safety considerations (occasionally).
• Electrical hazards and risk of electrical shock (occasionally).
• Potentially dangerous equipment (occasionally).

Vision demands include:

• Close vision (clear vision at 20 inches or less).
• Distance vision (clear vision at 20 feet or more).
• Color vision (ability to identify and distinguish colors).
• Peripheral vision.
• Depth perception.