Senior Regulatory Affairs Associate

Job Summary

Working collaboratively within a team of Regulatory Affairs professionals, the full-time Senior Regulatory Affairs Associate will ensure compliance with regulatory requirements, support the review of regulatory and clinical documents, and participate in key projects while engaging with internal and external partners.

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 or biological sciences
• 3-5 years of regulatory experience in the biologic or pharmaceutical industry
• Ability to utilize project planning skills for regulatory projects
• Proficiency in Microsoft Office Suite and data management systems
• Experience with technology automation and AI-assisted tools in regulated environments