Associate / Senior Associate – Regulatory Affairs (Drug Listing)

📋 Description

• Execute drug product lifecycle management for the North America region.
• Prepare and submit FDA regulatory submissions for launches and lifecycle updates.
• Write, review, and submit Drug Listing (DL) documentation.
• Evaluate, assign, and maintain NDC numbers for bulk and finished products per SOPs.
• Review, approve, and manage change controls affecting drug listing and regulatory impact.
• Ensure regulatory compliance, submission accuracy, and adherence to timelines.

🎯 Requirements

• 2–4 years of experience in Regulatory Affairs, Quality Assurance, Packaging, or Labelling.
• Experience with FDA submissions, drug listing activities, and regulatory documentation.
• Knowledge of NDC assignment processes and regulatory compliance requirements.
• Familiarity with regulatory document management systems.
• Strong organizational skills with attention to detail and compliance.
• Ability to manage timelines, coordinate cross-functional activities, and communicate effectively.