[Hiring] Manager, Regulatory Operations @START Center for Cancer Research

Role Description

We are seeking a Manager, Regulatory Operations (Remote). This role performs operational leadership for the Regulatory Operations function across START USA. The Manager, Regulatory Operations 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 (e.g., GCP, FDA BIMO, 21 CFR Part 11).

Essential Responsibilities:

• Provide direct people leadership for assigned team.
• Partner with the Regulatory Operations Leadership and Quality Assurance to set departmental goals and ensure timely execution of regulatory deliverables that support study startup, conduct, maintenance and close out.
• Oversee day to day regulatory operations to ensure submissions are accurate, complete and on time; balance workloads and assign/re-distribute studies based on capacity and complexity.
• Establish, maintain, and continuously improve SOPs, work instructions, templates, and training materials to drive standardization, quality, and scalability across sites.
• Maintain relationships with Institutional Review Board(s) (IRB) used and Sponsors/CROs.
• Supervise day-to-day activities of the Regulatory Operations staff to ensure that submissions are accurate, and deadlines are met.
• Monitor key metrics (e.g., turnaround times, aging, quality findings) and drive corrective actions and process improvements in partnership with Quality Assurance and cross-functional stakeholders.
• Serve as an escalation point for complex regulatory issues and facilitate timely resolution with IRBs, IBCs, FDA, Sponsors/CROs, and other departments.
• Attend SOP Committee Meetings quarterly, provide regulatory and data input, and revise any SOPs as needed per the meetings.
• Collaborate with other START departments, including Site Clinical departments and Shared Services departments, and Regional Director to provide support and leadership to effectively meet deadlines, prepare for audits, manage various electronic systems and START templates in use at START (i.e., FileMaker, CITI portal, study portals, e-signature platforms, etc.), and special projects as needed.
• Prepare and submit new studies, including drafting the informed consent (IC), to the IRB (local and hospital) as assigned.
• Prepare and submit study documents to the IRB (local and hospital) for assigned studies.
• Prepare and submit study documents to the Institutional Biosafety Committee (IBC) as assigned.
• Prepare and submit Expanded Access Studies to the US Food and Drug Administration (FDA) as assigned.
• Maintain the ISF (paper and/or electronic) for assigned studies.
• Prepare and manage Close-Out Visits for assigned studies.

Qualifications

• Bachelor’s degree or equivalent experience in lieu of degree.
• 5+ years of progressive experience in a regulatory research setting, including oversight of new study submissions and ongoing maintenance and management experience.
• Proficiency with Microsoft Office and Regulatory Data Tracking / Document Management Systems (e.g., Jira, Veeva, Advarra E-Reg).
• Excellent leadership, organizational, and communication skills with a high level of attention to detail.
• Advanced working knowledge of IRB, FDA, and IBC requirements with experience supporting audit/inspection readiness.

Requirements

• Travel required up to 10% of the time.
• Sitting for extended periods of time.
• Typing and computer use 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 for added financial protection.
• Employee Assistance Program (EAP) providing confidential, no-cost support for you and your family from day one.
• Flexible FSA and HSA plans to support your financial wellness.
• Commitment to a supportive environment that values balance, wellbeing, and flexibility.