Oncology Regulatory Affairs VP

Job Summary

A company is looking for a Vice President, Regulatory Affairs - Oncology.

Key Responsibilities

• Lead the development of regulatory strategies and manage IND and NDA submissions
• Guide regulatory agency interactions and ensure compliance with FDA regulations
• Oversee the regulatory activities at CROs and manage the commercial regulatory affairs function

Required Qualifications

• Advanced degree in a relevant scientific discipline; Doctoral degree preferred
• 15 years of biopharmaceutical experience with at least 10 years in Regulatory Affairs in Oncology
• Demonstrated experience in preparing strategies for and submitting INDs, NDAs, and MAAs
• Comprehensive knowledge of global regulations and guidelines
• Proven leadership skills in managing a functional team