Regulatory Affairs Analyst

Location: Remote
Pay Rate: $30–34/hour
Duration: 6 months

About the role

The Regulatory Affairs Analyst supports the launch of marketed products by developing mandatory product label text, regulated claims, and nutritional information in the form of Label Information Notes (LINs), and by tracking post-market regulatory surveillance. The candidate will conduct horizon scanning for the US market to prepare for future regulatory requirements, provide guidance to project teams, and ensure product compliance.

Responsibilities

• Analyze product formulations to provide mandated labelling content by collaborating with R&D scientists while delivering against desired marketing requirements in a compliant manner.
• Review and approve final product labels, ensuring compliance with local legislation and market authorizations.
• Ensure product formulations and ingredients comply with FDA regulations.
• Provide regulatory input for early innovation of new products by reviewing marketing concepts and claims for consumer studies.
• Ensure appropriate scientific support of US-based product claims to obtain the most competitive labelling possible.
• Monitor the regulatory and governmental environment and identify impact to products.
• Support label changes resulting from new or updated regulations.
• Manage regulatory projects to deliver against regulatory initiatives.
• Provide regular updates to matrixial teams on projects to ensure alignment in areas of responsibility.
• Manage all paper, electronic files, and information management databases.
• Enhance the effectiveness and efficiency of the Regulatory Affairs Department by supporting and improving various systems and processes.
• Build strong relationships within division/departments on both local and global levels and with external stakeholders.

Requirements

• University degree in a scientific field (B.S. in Food Science, Biology, Chemistry, Toxicology, or Nutrition) required; M.S. preferred.
• Minimum of 3 years of experience in Regulatory Affairs at a Consumer Products Company.
• Proficient in computer applications (MS Word, Excel, PowerPoint, Adobe Acrobat, Access, Optiva).