Associate Director/Director, Regulatory Affairs - Remote

Overview

The Associate Director of Regulatory Affairs will be a strategic thinker responsible for overseeing the regulatory assessment and research on regulatory precedence to evaluate regulatory strategies for development programs focused on precision medicine.

In Short

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

Requirements

• Advanced degree or B.S. in a science-related field.
• 8+ years of experience in regulatory affairs (preferably in oncology).
• Experience with successful submissions, preferably U.S. and E.U.
• Direct experience with FDA regulations and product development.
• Ability to analyze scientific data and regulations.
• Critical strategic thinker with solution-oriented mindset.
• Ability to prioritize multiple urgent priorities.
• Thorough understanding of eCTD submission requirements.
• Excellent written and oral communication skills.
• Fluent with Microsoft Office and Adobe Acrobat.

Benefits

• Market-competitive total rewards package.
• Base pay and annual performance bonus.
• Company equity.
• Generous health benefits.