Associate Director of Regulatory Affairs

Job Summary

A company is looking for an Associate Director, Regulatory Affairs.

Key Responsibilities

• Serve as Global Regulatory Lead for radiopharmaceutical programs
• Develop clinical and nonclinical regulatory strategies for therapeutic and diagnostic products
• Prepare and submit regulatory filings and lead interactions with regulatory authorities

Required Qualifications

• Bachelor's degree or higher
• 7 or more years of regulatory experience
• Experience with therapeutic and diagnostic radiopharmaceutical product development
• Knowledge of nonclinical and clinical regulatory strategy in oncology
• Previous experience interacting with Regulatory Authorities