Oncology Regulatory Affairs Lead

Job Summary

To support the regulatory affairs department, the full-time Oncology Regulatory Affairs Lead will develop regulatory strategies for new assignments, oversee submission activities, and provide expertise to project teams while working remotely from anywhere in the US.

Key responsibilities

• Develops and recommends regulatory strategies for new product planning and licensing due diligence
• Oversees the preparation and submission of complex regulatory documents, ensuring compliance with FDA and global health authority standards
• Interacts with FDA and global health authorities, facilitating project-related communications and meetings

Required qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred
• 9 years of pharmaceutical drug development experience
• Expertise in regulatory aspects of pharmaceutical drug development involving undefined frameworks
• Strong organizational skills with experience managing large projects and providing regulatory guidance
• Ability to effectively communicate and maintain relationships with cross-functional teams