Senior Regulatory Scientist

Job Summary

A company is looking for a Senior Regulatory Scientist to support a Solid Oral Phase II & III program.

Key Responsibilities

• Execute regional clinical trial submission strategies for US, EU, and China
• Prepare, review, and coordinate regulatory documents for clinical trial applications
• Lead cross-functional collaboration to ensure compliant submission packages

Required Qualifications

• 7-10+ years of regulatory affairs experience in clinical-stage drug development
• Solid experience with solid oral dosage programs strongly preferred
• Proven ability to work independently and deliver to aggressive timelines
• Strong understanding of Phase II & III regulatory requirements
• Bachelor's or advanced degree in a life science or related field (MS/PhD preferred)