Associate Director/Director, Regulatory Affairs - Remote

Overview

The Associate Director/Director of Regulatory Affairs will oversee regulatory assessments and research, focusing on precision medicine in oncology, and will be part of a high-performing regulatory team.

In Short

• Manage regulatory communication with global regulators.
• Ensure effective timeline management for submissions.
• Maintain compliance with regulatory applications.
• Advise cross-functional teams on regulatory strategies.
• Provide regulatory guidance on drug project teams.
• Coordinate with Regulatory Operations Team for submissions.
• Conduct Regulatory Intelligence and disseminate information.
• Review and approve promotional materials.
• Assist with regulatory business development efforts.

Requirements

• Advanced degree or B.S. in a science-related field.
• 8+ years of regulatory affairs experience (10+ for Director).
• Experience with U.S. and E.U. marketing applications.
• Direct experience with FDA regulations.
• Ability to analyze scientific data and regulations.
• Critical strategic thinker with oncology experience.
• Ability to prioritize multiple urgent tasks.
• Understanding of eCTD submission requirements.
• Excellent written and oral communication skills.
• Fluent in Microsoft Office and Adobe Acrobat.

Benefits

• Annual salary range of $178,500 - $265,500.
• Annual bonus and stock-based incentives.
• Medical, dental, and vision benefits.
• Retirement and wellness stipend.
• Flexible time off.