Manager, Regulatory Operations

🔥 1 minute ago

🤠 Texas – Remote

🤠 Texas – Remote

💵 $110k - $135k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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The START Center for Cancer Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare • Pharmaceuticals • Biotechnology

The START Center for Cancer Research is a global clinical research organization focused on early-phase oncology trials and advancing cancer therapies. START operates large, world-class research facilities across the United States and Europe and runs programs (such as the START Hope Hub) to help patients and families find, understand, and enroll in clinical trials. START serves patients, referring physicians, hospitals and oncology practices, and pharmaceutical partners, emphasizing broad access to clinical trials and translational cancer research.

📋 Description

• 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

• 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

• 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