Senior Manager of Regulatory Affairs

Job Summary

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

Key Responsibilities

• Manage regional regulatory activities as part of the Global Regulatory Team
• Lead the preparation and coordination of US regulatory submissions and responses to health authority information requests
• Review nonclinical, clinical, and CMC documentation, contributing to content as needed

Required Qualifications

• B.S. degree, preferably in a scientific discipline
• 4 years of experience in the biopharmaceutical or pharmaceutical industry, with a focus on regulatory affairs
• Experience with electronic regulatory submissions and regulatory templates
• Solid understanding of FDA and ICH regulations related to clinical research and product development
• Familiarity with EU Clinical Trial Regulation and ROW country regulatory requirements is a plus