Senior Manager - Oncology Regulatory

Job Summary

A company is looking for a Senior Manager - US Regulatory Affairs Lead-Oncology.

Key Responsibilities

• Develop and implement regional regulatory strategies and manage effective agency interactions
• Ensure regulatory compliance and support clinical trials for investigational medicinal products
• Plan and manage regulatory submissions for products within the company's portfolio in compliance with local regulatory requirements

Required Qualifications

• Doctorate degree and 2 years of Regulatory experience, or Master's degree and 4 years, or Bachelor's degree and 6 years, or high school diploma/GED and 12 years of Regulatory experience
• Preferred qualifications include MS, PharmD, or PhD
• Contemporary Oncology Regulatory experience is preferred
• Understanding of national regulations and drug development processes
• Experience with regulatory submissions and interactions with regulatory agencies