Senior Manager of Regulatory Affairs

Job Summary

A company is looking for a Senior Manager, Regulatory Affairs to manage and support a team while developing regulatory strategies for Transfusion Medicine projects.

Key Responsibilities

• Develop and implement regulatory strategies for project teams, including submission pathways and clinical efficacy requirements
• Interact with regulatory personnel to expedite applications and resolve regulatory matters, ensuring compliance with submission requirements
• Lead process improvement projects to enhance departmental efficiencies and mentor junior staff in regulatory affairs

Required Qualifications

• Bachelor's degree in a scientific or related discipline or equivalent experience
• 10+ years of experience in a regulated In Vitro Diagnostics or Biologics industry
• 7+ years of experience developing regulatory strategies for complex projects requiring US FDA submissions
• Previous people management experience
• Experience with product labeling and promotional content review