Massachusetts Licensed Regulatory Director

Job Summary

A company is looking for an Associate Director, Global Regulatory Project Management and Strategic Planning.

Key Responsibilities

• Partner with the Global Regulatory Lead to establish and maintain global regulatory project plans and ensure seamless execution of goals
• Lead cross-functional submission working groups to deliver successful regulatory submissions and provide project management oversight
• Prepare reports on regulatory milestone status and collaborate with stakeholders to present operational strategies and plans

Required Qualifications

• Bachelor's degree required, with an emphasis in Science preferred; advanced degree preferred
• Minimum of 8 years of related experience, including 4 years in Global Regulatory Affairs
• Experience with late-stage filings is highly preferred
• Significant experience in global drug development regulations and regulatory submissions
• Proven ability to provide regulatory operational support and guidance