Senior Director of Regulatory Operations

Job Summary

A company is looking for a Senior Director, Regulatory Operations - Phase 1 Oncology Site.

Key Responsibilities

• Build and manage scalable regulatory operations processes for Phase 1 oncology studies across US and EU
• Ensure seamless integration of regulatory processes into clinical operations workflows and study startup
• Lead a Regulatory Operations team and serve as the primary point of contact for regulatory submissions and documentation

Required Qualifications

• Bachelor's degree in life sciences, public health, regulatory affairs, or a related field
• 5-10 years of Regulatory Operations experience within clinical research, preferably in oncology Phase 1
• Proven experience with IRB/EC submissions and maintaining inspection readiness
• Deep understanding of ICH-GCP, regulatory document control principles, and eReg/Veeva systems
• Familiarity with 21 CFR Parts 50/56/312 and EU CTR operational processes