Manager, Regulatory Operations

This is a fully remote position, open to applicants in Texas.

📋 Description

• Provide direct leadership to the assigned team.

• Collaborate with Regulatory Operations Leadership and Quality Assurance to establish departmental objectives and implement regulatory deliverables.

• Oversee daily regulatory operations, ensuring submissions are precise, comprehensive, and timely.

• Balance workloads and allocate or reassign studies based on capacity and complexity.

• Develop, maintain, and enhance SOPs, work instructions, templates, and training materials.

• Cultivate relationships with IRBs and Sponsors/CROs.

• Supervise Regulatory Operations personnel and ensure deadlines are adhered to.

• Monitor turnaround times, aging, quality findings, and initiate corrective actions and process enhancements.

• Escalate and address complex regulatory issues with IRBs, IBCs, FDA, Sponsors/CROs, and other departments.

• Participate in quarterly SOP Committee Meetings, offering regulatory and data insights, and revise SOPs as necessary.

• Collaborate with START departments and the Regional Director regarding deadlines, audits, electronic systems, templates, and special projects.

• Prepare and submit new studies and informed consents to local and hospital IRBs.

• Act as the primary liaison with Sponsors/CROs and IRBs for assigned studies.

• Track submission dates, pending information, and status reports in FileMaker.

• Prepare and submit study documentation, 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 both paper and electronic Investigator Site Files.

• Prepare and oversee study Close-Out Visits.

⛳️ Requirements

• Bachelor’s degree or equivalent experience in lieu of a degree.

• Over 5 years of progressive experience in a regulatory research environment.

• Familiarity with managing new study submissions and ongoing maintenance.

• Proficiency in Microsoft Office.

• Expertise in Regulatory Data Tracking / Document Management Systems, such as Jira, Veeva, and Advarra E-Reg.

• Exceptional leadership, organizational, and communication abilities.

• High degree of attention to detail.

• Advanced knowledge of IRB, FDA, and IBC requirements.

• Experience in supporting audit/inspection readiness.

• Willingness to travel up to 10% of the time.

• Capability to sit for extended periods.

• Ability to type and use a computer for prolonged periods.

🏝️ Benefits

• 401(k) retirement savings plan with employer matching.

• Eligibility for an annual performance bonus, contingent upon role and company performance.

• Generous paid time off and paid holidays.

• Comprehensive medical, dental, and vision coverage along with optional insurance choices.

• Company-funded life and disability insurance.

• Employee Assistance Program (EAP) offering confidential, no-cost support for you and your family from day one.

• Flexible FSA and HSA plans.

• Supportive environment that prioritizes balance, wellbeing, and flexibility.

• Opportunities for continuous learning and professional development.

• Collaborative, inclusive, and innovative workplace.