Remote Regulatory Operations Manager

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

Benefits offered by this job

401(k) employer match

Annual performance bonus

Paid time off and holidays

Medical, dental, vision coverage

Life and disability insurance

Employee Assistance Program (EAP)

FSA/HSA options

Job summary

START Research seeks a Manager, Regulatory Operations (Remote) to lead regulatory activities for START USA. You will oversee submissions, ISFs, and team performance, ensuring compliance with IRB, IBC, and FDA requirements while driving process improvements.

The role emphasizes leadership, collaboration, and standardization across sites, with a base salary of $110,000–$135,000 per year and comprehensive benefits. Remote work is supported, with travel up to 10% as needed.

Qualifications

• Bachelor’s degree or equivalent experience.
• 5+ years in regulatory research with oversight of submissions and maintenance.
• MS Office and regulatory data tracking systems (Jira, Veeva, Advarra E-Reg).
• Excellent leadership, organizational, and communication skills with attention to detail.
• Advanced knowledge of IRB, FDA, and IBC requirements; audit/inspection readiness.

Responsibilities

• Provide direct people leadership for the assigned team.
• Lead goals with Regulatory Operations Leadership and QA; ensure timely regulatory deliverables.
• Oversee submissions to ensure accuracy, timely completion, and workload balance.
• Establish and improve SOPs, templates, and training for standardization and scalability.
• Maintain IRB relationships with IRBs and Sponsors/CROs.
• Supervise daily Regulatory Operations activities to meet deadlines.
• Monitor metrics and drive corrective actions with QA and stakeholders.
• Escalate complex regulatory issues and coordinate with IRBs, IBCs, FDA, and Sponsors/CROs.
• Attend SOP Committee meetings; provide regulatory input and update SOPs.
• Collaborate with other START departments and Regional Director to meet deadlines and manage systems.
• Prepare and submit new studies, draft ICs, coordinate with IRB and Sponsor; track in FileMaker.
• Prepare and submit study documents to IRB and IBC; manage status reports.
• Submit Expanded Access studies to FDA; respond to inquiries.
• Maintain ISF for assigned studies and manage close-out visits.

Skills

Leadership

Communication

Regulatory submissions

IRB/FDA knowledge

Audit readiness

Education

Bachelor’s degree or equivalent experience

Tools

Microsoft Office

Jira

Veeva

Advarra E-Reg

Job description

START Research seeks a Manager, Regulatory Operations (Remote) to lead regulatory activities for START USA. You will oversee submissions, ISFs, and team performance, ensuring compliance with IRB, IBC, and FDA requirements while driving process improvements.

The role emphasizes leadership, collaboration, and standardization across sites, with a base salary of $110,000–$135,000 per year and comprehensive benefits. Remote work is supported, with travel up to 10% as needed.