Director, Regulatory Strategy & Operations (Oncology)

Astera Cancer Care; Northern (KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

OneOncology seeks a Director of Regulatory Affairs to lead strategic and operational regulatory activities across its research network. You will guide FDA/GCP compliance, IRB submissions, and eTMF management while partnering with site leads and senior leadership.

Responsibilities include building a central regulatory team, standardizing processes, driving start-up efficiency, and ensuring audit readiness across trials. Oncology expertise preferred.

Qualifications

• Bachelor’s degree required; Master’s preferred.
• Minimum 8 years in regulatory affairs in clinical research; oncology experience highly desired.
• 3+ years leading regulatory staff in a multi-site or network setting.
• Deep knowledge of FDA regulations (21 CFR Parts 50, 54, 56, 312) and ICH GCP; experience with sIRB.
• Experience with TMF/eTMF management and eTMF platforms (Veeva Vault, Complion).
• Ability to build scalable processes and regulatory infrastructure.

Responsibilities

• Develop and operationalize network-wide regulatory strategy, SOPs, policies, and governance.
• Oversee site activation regulatory activities, IRB submissions, eTMF setup, and start-up metrics.
• Build and manage a central regulatory team; define roles and career paths.
• Provide oversight and guidance across partner practices; support complex regulatory questions.
• Maintain audit readiness and regulatory metrics; deliver training programs.

Skills

Regulatory leadership

GCP/IRB knowledge

Process improvement

Cross-functional collaboration

Education

Bachelor's degree (Master’s preferred)

Tools

Veeva Vault / Complion / eTMF

OnCore / Medidata CTMS

IRB submission tools

Job description

OneOncology seeks a Director of Regulatory Affairs to lead strategic and operational regulatory activities across its research network. You will guide FDA/GCP compliance, IRB submissions, and eTMF management while partnering with site leads and senior leadership.

Responsibilities include building a central regulatory team, standardizing processes, driving start-up efficiency, and ensuring audit readiness across trials. Oncology expertise preferred.