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 documentation, and ensure compliance with FDA submissions.

Key responsibilities

• Support the US Regulatory Lead in the development and submission of IND applications, BLAs, and NDAs
• Create and maintain regulatory history documents and coordinate the collection of functional documents for regulatory applications
• Participate in Global Regulatory Teams and assist with meeting management and documentation for regulatory deliverables

Required qualifications

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