Oncology Regulatory Affairs Director

OneOncology; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

OneOncology seeks a Director, Regulatory Affairs to lead strategic and operational regulatory functions across its research network. The role will ensure FDA, ICH, IRB compliance and drive readiness for a growing portfolio of industry-sponsored trials.

The successful candidate will build and lead a central regulatory team, partner with site staff, and advise senior leadership on risk, resourcing, and regulatory innovation.

Qualifications

• Bachelor’s degree required; Master’s preferred.
• Minimum 8 years of regulatory affairs experience in clinical research; 3+ years in oncology.
• 3+ years managing regulatory staff in a multi-site or network setting.
• Deep knowledge of FDA regulations (21 CFR Parts 50, 54, 56, 312), ICH E6(R3) GCP, and sIRB platforms.

Responsibilities

• Develop and operationalize the network-wide regulatory strategy, SOPs, policies, and governance framework.
• Oversee IRB submissions, TMF/eTMF management, and audit preparation across partner sites.
• Lead central regulatory team and define roles, performance standards, and career pathways.
• Provide guidance to site regulatory leads and ensure regulatory readiness across trials.

Skills

Regulatory affairs

Oncology

Leadership

GCP

FDA regulations

IRB

eTMF

Cross-functional

Communication

Education

Bachelor’s degree

Master’s degree preferred

Tools

Veeva Vault

Complion

eTMF platforms

CTMS (OnCore etc)

Job description

OneOncology seeks a Director, Regulatory Affairs to lead strategic and operational regulatory functions across its research network. The role will ensure FDA, ICH, IRB compliance and drive readiness for a growing portfolio of industry-sponsored trials.

The successful candidate will build and lead a central regulatory team, partner with site staff, and advise senior leadership on risk, resourcing, and regulatory innovation.