Manager, Regulatory Operations

About this role

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager, Regulatory Operations based in the United States.

This is an opportunity to lead regulatory operations for a growing oncology clinical research network dedicated to advancing access to innovative cancer treatments.
In this managerial role, you will oversee a team of regulatory professionals and ensure high-quality, timely, and compliant clinical research documentation across multiple sites.
You will play a key role in streamlining regulatory submissions, strengthening inspection readiness, and standardizing processes and workflows.
Working closely with Quality Assurance, clinical teams, Institutional Review Boards (IRBs), sponsors, and contract research organizations (CROs), you will help maintain operational excellence throughout the clinical trial lifecycle.
The role combines people leadership, regulatory expertise, performance monitoring, and continuous improvement in a complex, highly regulated environment.
This fully remote position is ideal for an experienced regulatory professional who enjoys developing teams, solving complex challenges, and supporting research that can make a meaningful difference for patients.

### Accountabilities

- Lead, coach, and develop Regulatory Operations team members, including specialists and assistants, while overseeing workload allocation, study assignments, and team performance.
- Partner with Regulatory Operations leadership and Quality Assurance to establish departmental goals and deliver regulatory milestones supporting study startup, conduct, maintenance, and closeout.
- Oversee regulatory submissions to ensure accuracy, completeness, compliance, and timely delivery across assigned studies and sites.
- Develop, maintain, and improve standard operating procedures (SOPs), work instructions, templates, and training materials to promote consistency, quality, and scalability.
...