Senior Regulatory Affairs Manager

Job Summary

A company is looking for a Senior Manager in 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 Health Authority interactions

Required Qualifications

• Bachelor's degree or higher
• 5 or more years of hands-on regulatory experience
• Experience with therapeutic and diagnostic radiopharmaceutical product development
• Familiarity with nonclinical and clinical regulatory strategy in oncology
• Demonstrable record of strong leadership in a fast-paced environment