Regulatory Affairs Specialist

About This Role

This role focuses on ensuring compliance with FDA regulations across various product categories, including cosmetics, food supplements, food beverages, and hazardous household products. The specialist will manage product registrations, prepare regulatory documents, and maintain accurate documentation.

Responsibilities

• Ensure FDA compliance for categories such as cosmetics, food supplements, food beverages, and household urban hazardous products
• Ensure timely approval of product registrations and that all licenses are updated
• Prepare, review, and submit regulatory documents for FDA applications, amendments, variations, and renewals
• Maintain accurate and up-to-date regulatory documentation, including dossiers, technical files, and records of submission and approvals
• Review product labeling and packaging to ensure compliance with regulatory standards
• Prepare communication to regulatory agencies relative to product registrations, follow-ups, and compliances
• Stay updated on existing and new issuances and guidelines of the FDA and other regulatory agencies
• Create and regulate standard operating procedures in compliance with FDA standards to implement good practices at all times
• Perform other duties that may be assigned

Requirements

• Graduate of BS Pharmacy
• At least one year of experience

Important Details

• Start date: ASAP