US Regulatory Affairs Manager

Job Summary

A company is looking for a US Regulatory Lead.

Key Responsibilities

• Support the Global Regulatory Team in US Regulatory Activities, including IND development and submission
• Act as the primary point of contact with regulatory agencies and manage local regulatory submissions
• Provide guidance on local mechanisms to optimize product development and ensure compliance with regulations

Required Qualifications

• Doctorate degree OR
• Master's degree and 3 years of regulatory or drug development experience OR
• Bachelor's degree and 8 years of industry experience OR
• Associates degree and 10 years of Regulatory Affairs experience OR
• High school diploma/GED and 12 years of relevant experience