About this role
Accountabilities: Lead, coach, and develop Regulatory Operations team members, including specialists and assistants, while overseeing workload allocation, study assignments, and team performance. Partner with Regulatory Operations leadership and Quality Assurance to establish departmental goals and deliver regulatory milestones supporting study startup, conduct, maintenance, and closeout. Oversee regulatory submissions to ensure accuracy, completeness, compliance, and timely delivery across assigned studies and sites. Develop, maintain, and improve standard operating procedures (SOPs), work instructions, templates, and training materials to promote consistency, quality, and scalability. Manage relationships and serve as a key point of contact for IRBs, Institutional Biosafety Committees (IBCs), sponsors, CROs, and other regulatory stakeholders. Oversee the preparation and submission of new study applications, informed consent documents, protocol amendments, investigator brochures, continuing review reports, closure reports, safety reports, protocol deviations, waivers, and other required documentation. Coordinate expanded access study submissions to the U.S. Food and Drug Administration (FDA), as assigned, and manage follow-ups, inquiries, and outstanding regulatory requirements. Maintain complete, accurate, and inspection-ready Investigator Site Files (ISFs), in paper or electronic format, throughout the study lifecycle. Monitor key performance indicators, including submission turnaround times, aging items, and quality findings, and implement corrective actions and process improvements with cross-functional partners. Act as an escalation point for complex regulatory matters and facilitate timely resolution of issues involving IRBs, IBCs, the FDA, sponsors, CROs, and internal teams. Participate in quarterly SOP committee meetings, contribute regulatory and data insights, and update procedures as needed. Collaborate with clinical site teams, shared services, regional leadership, and other departments to support audits, deadlines, electronic systems, special projects, and regulatory workflow improvements. Coordinate study closeout visits and ensure all associated regulatory documentation and follow-up activities are completed. Support accurate regulatory tracking and reporting through systems and platforms such as FileMaker, CITI, study portals, and electronic signature tools. Requirements Bachelor's degree or equivalent relevant professional experience in lieu of a degree. At least 5 years of progressively responsible experience in a regulatory research environment, including new study submissions and ongoing regulatory document management. Demonstrated experience leading or supervising teams, coordinating workloads, and supporting employee development. Advanced working knowledge of IRB, FDA, and IBC requirements, as well as applicable Good Clinical Practice (GCP), FDA Bioresearch Monitoring (BIMO), and 21 CFR Part 11 requirements. Experience maintaining inspection-ready regulatory documentation and supporting audits or regulatory inspections. Proficiency with Microsoft Office and regulatory data-tracking or document-management systems, such as Jira, Veeva, or Advarra E-Reg. Strong organizational, leadership, communication, and problem-solving skills, with exceptional attention to detail and the ability to manage multiple priorities and deadlines. Ability to collaborate effectively with internal teams and external stakeholders, resolve complex regulatory issues, and drive continuous improvement. Availability to travel up to 10% of the time. Ability to work remotely while managing extended periods of computer use, typing, and seated work. Benefits Annual base salary: $110,000–$135,000, with the final offer depending on factors such as location, relevant knowledge, skills, and experience. Eligibility for an annual performance bonus based on role and organizational results. 401(k) retirement savings plan with employer matching. Generous paid time off and paid holidays. Comprehensive medical, dental, and vision insurance, with optional additional insurance coverage. Employer-paid life and disability insurance. Employee Assistance Program (EAP), offering confidential, no-cost support for employees and their families from day one. Flexible Spending Account (FSA) and Health Savings Account (HSA) options. Fully remote work arrangement. A collaborative and inclusive working environment that encourages professional development, continuous learning, shared ideas, and employee well-being. How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1
- LOCATION
- Remote · US, United States
- WORK MODE
- Remote
- JOB TYPE
- Full-time
- POSTED
- Oct 28, 2026
Source: Jobgether Careers