Remote Regulatory Operations Manager, Oncology Trials

The START Center for Cancer Research; San Antonio (TX); Remote; USD 110,000 - 135,000; Full time

Benefits offered by this job

401(k) match

Annual bonus

Paid time off

Medical, dental, and vision coverage

Life and disability insurance

Employee Assistance Program

Flexible FSA/HSA

Job summary

The START Center for Cancer Research is seeking a Manager, Regulatory Operations to lead a remote team responsible for regulatory submissions and maintenance of inspection-ready ISFs across START USA. This role focuses on driving standardization, training, and process improvements in IRB, IBC, and FDA interactions.

The successful candidate will oversee submissions, metrics, and cross-functional collaboration to ensure high-quality regulatory deliverables and audit readiness across sites.

Qualifications

• Bachelor’s degree or higher, or equivalent experience.
• 5+ years of progressive regulatory operations experience, including submissions and maintenance.
• Proficiency with Microsoft Office and regulatory data tracking / document management systems (e.g., Jira, Veeva, Advarra E-Reg).
• Excellent leadership, organizational, and communication skills with attention to detail.
• Advanced knowledge of IRB, FDA, and IBC requirements with audit/inspection readiness experience.

Responsibilities

• Provide direct people leadership for the Regulatory Operations team.
• Set departmental goals and ensure timely regulatory deliverables for studies.
• Oversee submissions to ensure accuracy, timeliness, and consistency.
• Develop and maintain SOPs, templates, and training materials.
• Maintain relationships with IRBs and Sponsors/CROs.
• Monitor metrics and drive corrective actions with QA and stakeholders.
• Serve as escalation point for regulatory issues with IRBs, IBCs, FDA.
• Coordinate submissions and keep FileMaker and portals updated.

Skills

People leadership

Regulatory operations

Cross-functional collaboration

Attention to detail

Education

Bachelor’s degree or equivalent experience

Tools

Microsoft Office

Jira

Veeva

Advarra E-Reg

Job description

The START Center for Cancer Research is seeking a Manager, Regulatory Operations to lead a remote team responsible for regulatory submissions and maintenance of inspection-ready ISFs across START USA. This role focuses on driving standardization, training, and process improvements in IRB, IBC, and FDA interactions.

The successful candidate will oversee submissions, metrics, and cross-functional collaboration to ensure high-quality regulatory deliverables and audit readiness across sites.