Director, Regulatory Affairs

OneOncology is positioning community oncologists to drive the future of medical care through a patient-centric, physician-driven, and technology-powered model to help improve the lives of everyone living with cancer and other diseases. Our team is bringing together leaders to the market place to help drive OneOncology’s mission and vision.

Why join us? This is an exciting time to join OneOncology. Our values-driven culture reflects our startup enthusiasm supported by industry leaders in oncology, urology, technology, and finance. We are looking for talented and highly-motivated individuals who demonstrate a natural desire to improve and build new processes that support the meaningful work of independent physicians and the patients they serve.

Job Description

The Director, Regulatory Affairs provides strategic and operational leadership for all regulatory functions across the OneOncology research network. This role serves as the central regulatory authority for a growing portfolio of industry-sponsored clinical trials, ensuring consistent compliance with FDA regulations, GCP, ICH guidelines, IRB requirements, and OneOncology’s internal standards across all practice partner sites. The successful candidate will build and lead a high-performing central regulatory team, partner closely with site-level regulatory staff, and serve as a key strategic advisor to VP Research and senior leadership on regulatory risk, readiness, and innovation.

Responsibilities

Strategic Regulatory Leadership

• Develop and operationalize the network-wide regulatory strategy, SOPs, policies, and governance framework.
• Serve as a subject matter expert (SME) for FDA regulations and applicable state regulations as it pertains to research regulatory affairs.
• Monitor evolving FDA guidance, NIH policy, and industry best practices; proactively adapt network processes.
• Represent OneOncology in sponsor/CRO regulatory meetings, audits, and pre-submission