Manager, Regulatory Operations (Remote)

START Center for Cancer Research • San Antonio, TX

1d • $110,000 - $135,000 • Remote

About The Position

The Manager, Regulatory Operations provides operational leadership for the Regulatory Operations function across START USA. The role leads and develops a team of Specialists and Assistants to ensure timely, accurate, and compliant regulatory submissions and maintenance of inspection-ready Investigator Site Files (ISFs). The manager is accountable for team performance, process standardization, metrics, training and onboarding, and continuous improvement of systems and workflows supporting IRB, IBC, and FDA interactions, in alignment with applicable regulations and guidelines such as GCP, FDA BIMO, and 21 CFR Part 11.

The position oversees day-to-day regulatory operations and assigned study activities, including study submissions and ongoing maintenance, IRB and IBC submissions, expanded-access submissions to the FDA, ISF maintenance, and study close-out visits. It works with Regulatory Operations Leadership, Quality Assurance, Sponsors/CROs, IRBs, IBCs, FDA, START departments, and other stakeholders to support study startup, conduct, maintenance, closeout, audit readiness, and timely resolution of regulatory issues.

This is a remote position with a Monday-Friday, 8:00 a.m.-5:00 p.m. work schedule and travel required up to 10% of the time. The annual base salary is $110,000-$135,000, with pay potentially varying based on market location and job-related knowledge, skills, and experience.

Requirements

• Bachelor’s degree or equivalent experience in lieu of a degree.
• At least 5 years of progressive experience in a regulatory research setting, including oversight of new study submissions and experience with ongoing study maintenance and management.
• Proficiency with Microsoft Office and regulatory data tracking/document management systems, such as Jira, Veeva, or Advarra E-Reg.
• Excellent leadership, organizational, and communication skills, with strong attention to detail.
• Advanced working knowledge of IRB, FDA, and IBC requirements.
• Experience supporting audit and inspection readiness.

Responsibilities

• Provide direct people leadership for the assigned team.
• Partner with Regulatory Operations Leadership and Quality Assurance to set departmental goals and ensure timely execution of regulatory deliverables supporting study startup, conduct, maintenance, and closeout.
• Oversee day-to-day regulatory operations, ensuring submissions are accurate, complete, and timely; balance workloads and assign or redistribute studies based on capacity and complexity.
• Establish, maintain, and continuously improve SOPs, work instructions, templates, and training materials to promote standardization, quality, and scalability across sites.
• Maintain relationships with Institutional Review Boards and Sponsors/CROs.
• Supervise Regulatory Operations staff to ensure accurate submissions and on-time completion of deadlines.
• Monitor metrics such as turnaround times, aging, and quality findings, and drive corrective actions and process improvements with Quality Assurance and cross-functional stakeholders.
• Serve as an escalation point for complex regulatory issues and facilitate resolution with IRBs, IBCs, FDA, Sponsors/CROs, and other departments.
• Attend quarterly SOP Committee Meetings, provide regulatory and data input, and revise SOPs as needed.
• Collaborate with START Site Clinical and Shared Services departments and Regional Directors to meet deadlines, prepare for audits, manage electronic systems and templates, and support special projects.
• Prepare and submit new studies to local and hospital IRBs, including drafting informed consent documents when assigned; negotiate informed consent documents with Sponsors/CROs and serve as the main point of contact with IRBs for assigned studies.
• Record submission dates in FileMaker, track pending information, generate status reports, respond to inquiries, and follow up on pending items.
• Prepare and submit assigned study documents to local and hospital IRBs, including revised protocols and investigator brochures, clarification letters or memos, informed consent documents, continuing review and closure reports, serious adverse events, IND safety reports, unanticipated problems, protocol deviations, and waivers.
• Prepare and submit assigned study documents to the IBC; serve as the study contact and track submissions, pending information, status reports, inquiries, and follow-up.
• Prepare and submit assigned Expanded Access Studies to the FDA; serve as the FDA and IRB contact and track submissions, pending information, status reports, inquiries, and follow-up.
• Maintain paper and/or electronic ISFs for assigned studies, including IRB submissions and approvals, study documents, and study correspondence.
• Prepare and manage close-out visits for assigned studies.

Benefits

• 401(k) retirement savings plan with employer match.
• Eligibility for an annual performance bonus based on role and company results.
• Paid time off and paid holidays.
• Medical, dental, and vision coverage, with optional insurance options.
• Company-paid life and disability insurance.
• Employee Assistance Program providing confidential, no-cost support for employees and their families from day one.
• Flexible FSA and HSA plans.
• A supportive environment that values balance, wellbeing, and flexibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager