Associate Director, Regulatory Affairs

Overview

Critical role in developing and implementing regulatory plans for drug development.

Ideal candidate should have 8+ years of regulatory affairs experience in bio/pharmaceuticals with FDA interaction.

Locations

• United States

Requirements

• Bachelor's degree required
• 8+ years in drug development
• Experience with FDA required
• Psychiatry or Neurology experience preferred
• Ability to travel up to 25%

Responsibilities

• Lead NDA submission initiatives
• Manage regulatory projects
• Develop regulatory strategies
• Participate in FDA meetings
• Interact with regulatory agencies
• Advise teams on development issues
• Collaborate with consultants
• Monitor regulatory changes

Benefits

• 100% paid health benefits
• 401(k) with company match
• Flexible time off
• Generous parental leave
• Fringe perks