Regulatory Specialist

2 weeks ago

Skokie, United States Sterling Engineering Full time

ROLE SUMMARY:

The Regulatory Specialist plays a crucial role in supporting internal and external stakeholders regarding regulatory matters. This position involves managing and prioritizing customer needs and requests related to specifications, questionnaires, labeling, kosher, nutritionals, and more. The specialist collaborates cross-functionally to assist R&D and sales teams and ensures that finished products adhere to all regulatory standards.


PRIMARY RESPONSIBILITIES:


  • Manage the review and approval of new ingredient documentation from suppliers, as well as any updated documentation according to established schedules.
  • Populate regulatory and labeling information in customer portals or questionnaires for new items and update as necessary for existing items.
  • Create and maintain internal and customer-facing product specifications.
  • Collaborate with cross-functional teams to incorporate compliance, labeling, and claim considerations into new product development meetings.
  • Conduct regulatory review of all product ingredient, formula, and packaging compliance.
  • Fulfill customer or internal requests for information with accurate and professional responses.
  • Review documentation to ensure labeling accuracy and claims substantiation.
  • Oversee the regulatory change control process to update labels, specifications, or documentation as required.
  • Ensure project timelines are met and communicate needs to meet established deadlines.
  • Manage customer requests and project work based on priorities established by management.
  • Ensure all regulatory records and files are complete and accurate.



KNOWLEDGE AND SKILL REQUIREMENTS:


  • Minimum of 2 years of regulatory experience.
  • Bachelor's degree in Nutrition, Food Science, Biology, or related discipline preferred; Associate's degree or equivalent work experience will be considered.
  • Strong proficiency with ESHA Genesis, TraceGains, Salesforce, and customer portals preferred.
  • Excellent organizational and critical thinking skills.
  • Ability to prioritize workload, manage multiple tasks, and work independently.
  • Strong communication skills, both written and oral.
  • Ability to foster collaborative team environments and work cross-functionally.
  • Capability to build strategic partnerships to advance departmental and organizational objectives.

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