Regulatory Affairs Specialist

4 days ago

Bloomingdale, Illinois, United States Now Foods Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Documentation Manager to join our team at Now Foods. This role will be responsible for supervising the preparation and submission of international new product registrations, renewals of registrations, certificates, and other required documents to regulatory authorities.

Key Responsibilities
  • Interact with government regulatory agencies (such as FDA, USDA, and international agencies as necessary) regarding registration processes for procedures requiring regulatory approval.
  • Function as the primary liaison between Sales, QA/QC/R&D, and the Purchasing Groups to obtain the necessary documentation supporting international and domestic trade requirements for all countries (excluding Canada) where NOW products are registered or sold.
  • Organize periodic meetings with Sales to determine project priorities and update progress on requested actions.
  • Provide technical supervision to the Documentation Team and serve as a regulatory resource for documentation requirements in the various countries where products are registered and where Sales request registration and documents.
  • Establish SOPs for registration and sales support and review and verify all QA information for Certificates of Free Sale, government-generated certificates, CofA, specifications, master formulas, FDA inspection reports, and GMP compliance.
Requirements
  • Strong knowledge of regulatory requirements and procedures for international product registration.
  • Excellent communication and interpersonal skills.
  • Ability to work effectively in a team environment.
  • Strong analytical and problem-solving skills.
  • Ability to prioritize tasks and manage multiple projects simultaneously.

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