Senior Regulatory Affairs Associate

Job Summary

A company is looking for a Senior Regulatory Affairs Associate.

Key Responsibilities

• Identify, assess, and execute regulatory process improvements and initiatives
• Represent the Regulatory Team on interdepartmental projects and external collaborations
• Assist with regulatory oversight and submissions for trials where the company is the Sponsor

Required Qualifications

• B.S. degree or higher in a scientific field such as biochemistry, biological sciences, or pharmacy
• 3-5 years of previous regulatory experience in the device, biologic, or pharmaceutical industry
• Ability to utilize project planning skills for regulatory projects
• Experience with Microsoft Office Suite and data management systems
• Familiarity with regulatory compliance and relevant US FDA regulations