Senior Regulatory Affairs Associate

Job Summary

Joining a team of Regulatory Affairs professionals, the full-time Senior Regulatory Affairs Associate will ensure compliance with regulatory requirements by reviewing clinical documents, supporting regulatory submissions, and collaborating with internal and external partners in the cell and gene therapy space.

Key responsibilities

• Identifies and executes regulatory process improvements and initiatives independently
• Represents the Regulatory Team on interdepartmental projects and collaborates with external partners
• Assists with regulatory oversight and submissions for clinical trials where NMDP 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 regulatory experience in the device, biologic, or pharmaceutical industry
• Ability to utilize project planning skills to manage regulatory projects independently
• Experience with Microsoft Office Suite and data management systems
• Knowledge of US FDA regulations and guidance relevant to regulatory submissions