Manager, Regulatory Operations

The START Center for Cancer Research

. Provide direct people leadership for the assigned team .

Posted 10/27/2026full-timeRemote • Texas • United StatesMid-LevelSenior💰 $110,000 - $135,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory operations, including oversight of study submissions and compliance with IRB, FDA, and IBC requirements. Proven leadership in managing teams, improving processes, and ensuring timely regulatory deliverables.

Highest-signal resume keywords

Regulatory Operations LeadershipIRB, FDA, IBC ComplianceRegulatory Data Tracking SystemsStudy Submission ManagementAudit/Inspection Readiness

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsSOP DevelopmentDocument ManagementAttention to DetailStudy Protocol Preparation

Soft Skills

LeadershipOrganizational SkillsCommunication Skills

Tools & Technologies

Microsoft OfficeJiraVeevaAdvarra E-RegFileMaker

Industry Keywords

Regulatory ResearchClinical TrialsStudy Close-Out VisitsInformed ConsentSponsor/CRO Relationships

About the role

Key responsibilities & impact

Provide direct people leadership for the assigned team
Partner with Regulatory Operations Leadership and Quality Assurance to set departmental goals and execute regulatory deliverables
Oversee day-to-day regulatory operations, ensuring submissions are accurate, complete, and on time
Balance workloads and assign or redistribute studies based on capacity and complexity
Establish, maintain, and improve SOPs, work instructions, templates, and training materials
Maintain relationships with IRBs and Sponsors/CROs
Supervise Regulatory Operations staff and ensure deadlines are met
Monitor turnaround times, aging, quality findings, and drive corrective actions and process improvements
Escalate and resolve complex regulatory issues 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 departments and the Regional Director on deadlines, audits, electronic systems, templates, and special projects
Prepare and submit new studies and informed consents to local and hospital IRBs
Serve as primary contact with Sponsors/CROs and IRBs for assigned studies
Track submission dates, pending information, and status reports in FileMaker
Prepare and submit study documents, including protocols, investigator brochures, informed consents, continuing reviews, closure reports, safety reports, protocol deviations, and waivers
Prepare and submit study documents to Institutional Biosafety Committees
Prepare and submit Expanded Access Studies to the FDA
Maintain paper and electronic Investigator Site Files
Prepare and manage study Close-Out Visits

Requirements

What you’ll need

Bachelor’s degree or equivalent experience in lieu of degree
5+ years of progressive experience in a regulatory research setting
Experience with oversight of new study submissions and ongoing maintenance and management
Proficiency with Microsoft Office
Proficiency with Regulatory Data Tracking / Document Management Systems, such as Jira, Veeva, and Advarra E-Reg
Excellent leadership, organizational, and communication skills
High level of attention to detail
Advanced working knowledge of IRB, FDA, and IBC requirements
Experience supporting audit / inspection readiness
Willingness to travel up to 10% of the time
Ability to sit for extended periods of time
Ability to type and use a computer for extended periods of time

Benefits

Comp & perks

401(k) retirement savings plan with employer match
Eligibility for an annual performance bonus, based on role and company results
Generous paid time off and paid holidays
Comprehensive medical, dental, and vision coverage and optional insurance options
Company-paid life and disability insurance
Employee Assistance Program (EAP) providing confidential, no-cost support for you and your family from day one
Flexible FSA and HSA plans
Supportive environment that values balance, wellbeing, and flexibility
Continuous learning and professional growth
Collaborative, inclusive, and innovative workplace