Regulatory Affairs Manager

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Company: Katalyst HealthCares and Life Sciences

Location: Lake Zurich, IL 60047

Description:

Responsibilities:
  • The Regulatory Affairs Manager is responsible for providing regulatory compliance services to Merieux NutriSciences' customers in the food, supplement, pet food, and beverage industries, as well as other applicable regulated segments as the business needs grow.
  • The Regulatory Affairs Manager is also responsible for providing quality checks, continuous improvement activities, management of projects and team support.
  • Manages the review of product label projects and/or technical specifications to evaluate label copy, to ensure product compliance with all applicable labeling regulations.
  • Develop or create mandatory labeling materials, including building the ingredient list based on formulation provided, and nutrition facts panels using databases, nutrition testing and/or analytical calculations.
  • Provide consultation services on labeling compliance with customer inquiries or projects.
  • This includes providing technical feedback by reviewing documentation to substantiate labeling accuracy and claims.
  • Provide assessment on label claims; include defined nutrient/ health claims, factual claims, marketing callout, and romance copy.
  • Maintain up-to-date knowledge of current labeling regulations, regulatory activity and trends.
  • ttend webinars and conferences as necessary to stay up to date.
  • Complete industry training sessions as needed to stay current in regulatory knowledge.
  • Engage directly with sales, customers and the regulatory management by participating in key customer or prospect meetings, calls and management of projects.
  • ctively participate and support cross-functional departments on label compliance inquiries.
  • Support and assist in achieving departmental and organizational objectives.
  • Perform quality check on projects completed by other team members.
  • The position primarily works in an office/home office environment.
Requirements:
  • This person must be proficient interpreting and ensuring regulatory compliance in accordance with various regulatory requirements for the North American markets.
  • Minimum of 5 years of related work experience (Regulatory Compliance or Affairs, Food Labeling or related).
  • Strong demonstrated knowledge in food labeling regulations and policies for the US (FDA, USDA, CBP, FTC, TTB) and/ or Canada (Health Canada, CFIA).
  • Good understanding of food safety.
  • Demonstrate strong ability to explain and interpret complex regulations.
  • Demonstrated ability to identify labeling non-compliant issues.
  • Demonstrated ability in multi-tasking.
  • Strong communication skills, both written and verbal.
  • Strong interpersonal skills, comfortable working in a team setting.
  • Intermediate mathematical skills.
  • Strong system acumen and computer skills.
  • Proficient in Microsoft Office and Google applications.

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