Senior Clinical Regulatory Manager

Job Summary

A company is looking for a Senior Manager, Clinical Regulatory.

Key Responsibilities

• Manage regulatory aspects of clinical studies and create high-quality regulatory submissions
• Author and review clinical modules of applications and amendments for submission
• Evaluate clinical protocol changes and provide strategic regulatory guidance

Qualifications

• BA/BS in a scientific field and 8+ years of relevant experience
• Strong knowledge of regulatory requirements, especially in the US
• Demonstrated Regulatory Affairs experience commensurate with the role
• Industry experience in the development of biologics preferred
• Experience with a regulatory information management system is a plus