Lead, Regulatory Operations

The START Center for Cancer Research

. Serve as the regulatory subject-matter expert and provide guidance, training, and operational oversight to the Regulatory Operations team .

Posted 10/22/2026full-timeRemote • United StatesSenior💰 $80,000 - $105,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive regulatory expertise in clinical research, including proficiency in IRB, IBC, and FDA submission processes. Capable of leading and mentoring teams while ensuring compliance and accuracy in regulatory documentation.

Highest-signal resume keywords

Regulatory ExperienceIRB Submission RequirementsFDA Submission RequirementsSupervisory ExperienceQuality Control Reviews

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsClinical ResearchQuality ReviewsProcess ImprovementDocument PreparationRegulatory ComplianceWorkflow ManagementAudit PreparationCAPA DevelopmentStudy Protocols

Soft Skills

Organizational SkillsAttention to DetailTime ManagementMentoringCollaboration

Tools & Technologies

Microsoft WordFileMaker ProRegulatory Tracking Systems

Industry Keywords

Clinical StudiesInvestigator Site FilesStudy ApplicationsInformed Consent FormsRegulatory OperationsPhase I MeetingsSite Initiation VisitsSOP Development

About the role

Key responsibilities & impact

Serve as the regulatory subject-matter expert and provide guidance, training, and operational oversight to the Regulatory Operations team
Oversee complex regulatory submissions and support process improvement initiatives
Delegate and prioritize work as needed
Perform quality reviews to ensure compliance and accuracy
Prepare and submit regulatory documents for new and ongoing clinical studies to the IRB, FDA, and IBC
Ensure turnaround times are met and continually improve processes to achieve departmental goals
Prepare and submit new study applications and amendments to the IRB, including drafting and negotiating informed consent forms with Sponsors/CROs
Serve as the primary point of contact for assigned studies with the IRB, IBC, and FDA
Prepare and submit revised protocols, investigator brochures, safety reports, deviations, clarifications, continuing review reports, and closure documents
Prepare and submit Expanded Access and other complex or high-risk study submissions to the FDA
Track submissions in FileMaker or applicable systems and maintain accurate status updates
Maintain complete, accurate, and audit-ready Investigator Site Files in paper and electronic formats
Lead and manage regulatory close-out responsibilities for assigned studies
Train, mentor, and support Regulatory Operations team members
Perform quality control reviews of submissions and regulatory documents prepared by staff
Assist with work prioritization, workflow management, and cross-functional coordination
Serve as the escalation point for complex regulatory questions or study challenges
Attend and represent Regulatory Operations in weekly Phase I meetings, Protocol Review, and Site Initiation Visits
Collaborate with other departments to resolve regulatory issues and ensure timely submission of deliverables
Develop, revise, and implement Work Instructions and SOPs
Assist with regulatory file preparation for audits and inspections and participate in CAPA development
Partner with leadership to improve regulatory processes, systems, and standardization across START USA sites

Requirements

What you’ll need

Bachelor’s degree or equivalent experience
Minimum 5–7 years of regulatory experience in clinical research, including new study submissions
Previous supervisory experience leading, training, and onboarding direct reports
Advanced knowledge of IRB, IBC, and FDA submission requirements
Proficiency with Microsoft Word and FileMaker Pro or similar regulatory tracking systems
Exceptional organizational skills with attention to detail, accuracy, and completeness
Ability to independently manage multiple priorities, deadlines, and complex tasks
Ability to sit for extended periods of time
Ability to type and use a computer for extended periods of time

Benefits

Comp & perks

Medical, dental, and vision insurance
401(k) plan with employer matching
Life and disability insurance
Health savings and flexible spending accounts
Paid time off
Flexible schedule
Remote work choices
Collaborative, creative work environment
Learning and growth opportunities