Regulatory Affairs Associate

Job Summary

Supporting regulatory activities remotely, the full-time Senior Associate - Regulatory Affairs will assist in the creation and submission of regulatory documents, maintain product regulatory history, and ensure compliance with submissions to regulatory agencies.

Key responsibilities

• Assist U.S. Regulatory Lead with IND/BLA documentation and maintain regulatory history documents
• Review regional components of the Global Regulatory Plan and coordinate collection of functional documents for regulatory applications
• Prepare regulatory packages and provide regulatory support to Commercial, Medical, and Clinical departments through cross-functional interactions

Required qualifications

• Master's degree or Bachelor's degree with 2 years of Regulatory Affairs experience
• Associate's degree with 6 years of Regulatory Affairs experience or High school diploma/GED with 8 years of experience
• Experience in regulated industry, science, or clinical practice
• Strong organizational skills
• Ability to manage timelines effectively