Senior Manager, Regulatory Affairs

Job Summary

A company is looking for a Senior Manager, Global Regulatory Project Management and Strategic Planning.

Key Responsibilities

• Partner with Global Regulatory Lead on project plans and execute Global Regulatory Team goals
• Lead cross-functional submission working groups to ensure successful regulatory submissions and outcomes
• Provide regulatory operational support and oversee vendor activities for assigned programs

Required Qualifications

• Bachelor's degree required; emphasis in Science preferred, advanced degree preferred
• 6 years of related experience, with at least 4 years in regulatory affairs
• Significant experience in global drug development regulations and regulatory submissions
• Experience with eCTD and major filing processes in various jurisdictions preferred
• Advanced education or credentialing in regulatory affairs and project management preferred