Senior Associate Regulatory Affairs

Job Summary

A company is looking for a Senior Associate - Regulatory Affairs.

Key Responsibilities

• Assist in the creation and submission of regulatory documents and support US regulatory activities
• Provide and maintain IND/BLA documentation support and ensure compliance with submissions to regulatory agencies
• Coordinate collection of functional documents and facilitate participation in regulatory strategy implementation

Required Qualifications

• Master's degree OR Bachelor's degree with 2 years of Regulatory experience OR Associates degree with 6 years of Regulatory experience OR High school diploma/GED with 8 years of Regulatory experience
• Preferred Master's degree in biology, life science, health science, or regulatory science
• Experience in a regulated industry, science, or clinical practice
• Timeline management experience
• Organizational skills