Director, Regulatory Affairs (Oncology)

Location: United States; remote

Company

hirify.global is a technology-powered oncology research network supporting community oncologists, independent physician practices, and patients.

What you will do

• Develop and operationalize the network-wide regulatory strategy, SOPs, policies, and governance framework.
• Lead regulatory activities for site activation, including IRB submissions, essential documents, regulatory binders, eTMF configuration, and cycle-time metrics.
• Build, hire, develop, and manage the central regulatory team while establishing performance standards and capacity planning.
• Provide regulatory oversight to partner practices, conduct site assessments, manage onboarding readiness, and address performance gaps through CAPAs.
• Maintain audit-ready central and site regulatory files, oversee compliance reporting, and deliver GCP, regulatory, and protocol training.
• Drive adoption of eTMF, eISF, CTMS integrations, dashboards, and process automation to improve efficiency and audit readiness.

Requirements

• Bachelor’s degree required; Master’s degree preferred.
• At least 8 years of regulatory affairs experience in clinical research, including 3+ years in oncology.
• At least 3 years managing regulatory staff in a multi-site or network setting.
• Deep knowledge of FDA 21 CFR Parts 50, 54, 56, and 312; ICH E6(R3) GCP; and sIRB platforms such as WCG, Advarra, and NCI CIRB.
• Experience leading IRB submissions, TMF/eTMF management, audit preparation, and eTMF platforms such as Veeva Vault or Complion.
• Strong executive and sponsor communication skills, with the ability to build scalable regulatory processes and infrastructure from the ground up.

Nice to have

• RAC, SOCRA, or ACRP certification.
• Experience in a community oncology research network or with early-phase Phase I/II oncology trials and IND-held studies.
• Exposure to decentralized or hybrid clinical trial regulatory considerations.
• Working knowledge of OnCore, Medidata, or RealTime CTMS.
• Experience developing regulatory dashboards, cycle-time reporting, and change-management programs in matrixed organizations.

Culture & Benefits

• Values-driven culture combining startup enthusiasm with support from leaders in oncology, urology, technology, and finance.
• Opportunity to improve research operations for independent physicians and patients with cancer and other diseases.
• Cross-functional collaboration with Research Operations, Contracts, IT, data teams, sponsors, and practice partners.
• Focus on continuous improvement, regulatory excellence, scalable operations, and measurable reductions in site activation time.