Senior Director of Regulatory Operations

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