Senior Manager, Regulatory Operations

Job Summary

A company is looking for a Sr. Manager, Regulatory Operations.

Key Responsibilities

• Lead planning, preparation, publishing, and lifecycle management of regulatory submissions
• Ensure compliance with global regulatory requirements and manage submission timelines and content readiness
• Act as a subject matter expert in regulatory operations and drive continuous improvement initiatives

Required Qualifications

• Bachelor's degree in life sciences or related field required; advanced degree preferred
• 8+ years of regulatory operations experience in biotech or pharmaceutical industry
• Demonstrated experience supporting IND-stage, BLA/MAA, and marketed product submissions
• Hands-on experience with eCTD publishing and regulatory systems
• Strong knowledge of FDA, EMA, and global regulatory submission requirements