Remote Regulatory Operations Manager - Oncology Trials

Jobgether; Oregon; Hybrid; USD 110,000 - 135,000; Full time

Benefits offered by this job

Fully remote work arrangement

Annual salary bonus eligibility

401(k) with employer match

Paid time off and holidays

Comprehensive medical/dental/vision

Job summary

Jobgether is seeking a seasoned Regulatory Operations leader to oversee a growing oncology clinical research network. The role manages a team of regulatory professionals across sites, ensures timely, compliant documentation, and streamlines submissions, inspection readiness, and SOP standardization in a fully remote setup.

You will collaborate with QA, IRBs, sponsors, and CROs, drive performance metrics, develop staff, and guide study startup through closeout. Travel up to 10% may be required.

Qualifications

• Bachelor's degree or equivalent professional experience.
• 5+ years in regulatory research environment with submissions.
• Experience leading teams and coordinating workloads.
• Strong knowledge of IRB, FDA, IBC requirements and 21 CFR 11.

Responsibilities

• Lead, coach, and develop Regulatory Operations team members across sites.
• Partner to establish goals and deliver regulatory milestones for study startup through closeout.
• Oversee regulatory submissions for accuracy and compliance across studies.
• Develop and maintain SOPs, templates, and training materials.
• Manage relationships with IRBs, IBCs, sponsors, CROs.

Skills

Leadership

Regulatory knowledge

GCP & FDA rules

Documentation management

Communication

Problem solving

Education

Bachelor's degree or equivalent

Tools

Jira

Veeva

Advarra E-Reg

Job description

Jobgether is seeking a seasoned Regulatory Operations leader to oversee a growing oncology clinical research network. The role manages a team of regulatory professionals across sites, ensures timely, compliant documentation, and streamlines submissions, inspection readiness, and SOP standardization in a fully remote setup.

You will collaborate with QA, IRBs, sponsors, and CROs, drive performance metrics, develop staff, and guide study startup through closeout. Travel up to 10% may be required.