Regulatory Affairs Associate

Job Summary

Assisting in the creation and submission of regulatory documents, the full-time remote Regulatory Affairs Senior Associate will support US regulatory activities, maintain regulatory documentation, and collaborate with cross-functional teams to ensure compliance with FDA submissions.

Key responsibilities

• Support the US Regulatory Lead in the development and submission of IND, BLA, and NDA applications
• Maintain and archive regulatory documents and product regulatory history in the document management system
• Prepare supportive documentation for regulatory deliverables and coordinate responses to FDA inquiries

Required qualifications

• Master's degree in a relevant field
• Bachelor's degree with 2 years of regulatory or pharmaceutical experience
• Associate's degree with 6 years of regulatory or pharmaceutical experience
• High school diploma/GED with 8 years of regulatory or pharmaceutical experience