Regulatory Writing Senior Manager

Job Summary

A company is looking for a Regulatory Writing Senior Manager.

Key Responsibilities

• Author or oversee regulatory submission documents including Clinical Study Reports and Investigator Brochures
• Conduct formal reviews and approvals of authored documents following standard operating procedures
• Lead regulatory writing activities for complex product submissions with limited supervision

Required Qualifications

• Doctorate degree and 2 years of directly related experience, or
• Master's degree and 6 years of directly related experience, or
• Bachelor's degree and 8 years of directly related experience, or
• Associate's degree and 10 years of directly related experience, or
• High school diploma/GED and 12 years of directly related experience