Senior Clinical Regulatory Specialist

Regulatory Operations & Compliance

• Facilitate and oversee regulatory activities across the study lifecycle, including study start-up, site activation, maintenance, and closeout for Phase 2–4 industry-sponsored clinical trials.
• Provide regulatory guidance and oversight to research sites across multiple studies, ensuring timely and accurate completion of regulatory requirements.
• Review and QC regulatory documentation and submissions for completeness, accuracy, consistency, and compliance, identifying gaps and driving resolution.
• Manage complex regulatory activities and submissions, including IRB applications, amendments, continuing reviews, safety reports, unexpected events, and other study-specific regulatory requirements.
• Monitor regulatory timelines, approvals, expirations, and outstanding requirements to proactively identify potential delays or compliance risks.
• Identify, assess, and escalate regulatory risks and compliance issues, partnering with sites, sponsors, CROs, and internal stakeholders to develop and implement appropriate corrective and preventive actions.
• Serve as a subject matter resource for site teams and internal stakeholders on regulatory requirements, study-specific expectations, and best practices.
• Ensure regulatory documentation and processes remain consistent, compliant, and inspection-ready across the research network.
• Maintain accurate regulatory records, trackers, and documentation within applicable clinical research and regulatory systems.

Site Support & Relationship Management

• Serve as a senior regulatory point of contact for assigned research sites and act as a liaison between sites, sponsors, CROs, IRBs, and internal stakeholders.
• Provide guidance and mentorship to site teams on regulatory processes, documentation requirements, compliance expectations, and study-specific requirements.
• Partner with sites to proactively identify regulatory challenges, develop solutions, and drive timely resolution of outstanding issues.
• Build strong relationships with site teams and establish credibility as a trusted regulatory resource.
• Participate in monitor visits, QA/QC projects, site-level audits, and other quality activities, supporting inspection readiness and remediation of identified findings.
• Support sites in preparing for regulatory inspections and audits, including identifying documentation gaps and coordinating timely remediation.

Process Improvement & Regulatory Excellence

• Drive continuous improvement of regulatory processes, tools, and workflows across the clinical research network.
• Identify opportunities to improve efficiency, standardization, quality, and compliance across regulatory operations.
• Develop and maintain regulatory resources, templates, trackers, SOPs, and training materials to support consistent execution across sites.
• Support training, mentorship, and knowledge sharing for Clinical Regulatory Specialists and research site teams.
• Contribute to the development and implementation of network-wide regulatory strategies, processes, and best practices.
• Partner cross-functionally to identify trends, recurring issues, and opportunities to improve the overall site and study experience.
• Support the implementation and adoption of new regulatory systems, tools, and processes as the clinical research network scales.

What You Bring to the Team

• 4+ years of relevant experience in clinical research, clinical regulatory, and/or research operations supporting industry-sponsored clinical trials.
• Strong experience supporting Phase 2–4 sponsor-initiated clinical trials, ideally in a site-facing regulatory capacity.
• Previous experience as a Clinical Research Coordinator (CRC), Regulatory Coordinator/Specialist, or in another clinical research role with significant responsibility for regulatory activities
• Strong working knowledge of Good Clinical Practice (GCP), applicable FDA regulations and guidance, IRB processes, and clinical research SOPs.
• Demonstrated experience independently managing regulatory activities across multiple studies and/or research sites.
• Experience reviewing regulatory documentation and submissions for quality, completeness, and compliance.
• Strong organizational, time-management, and prioritization skills, with the ability to manage multiple studies, sites, deadlines, and competing priorities.
• Exceptional attention to detail and a commitment to maintaining accurate, complete, and inspection-ready documentation.
• Strong written and verbal communication skills with the ability to build effective relationships with site staff, sponsors, CROs, IRBs, and internal stakeholders.
• Demonstrated ability to work independently, exercise sound judgment, and take ownership of complex regulatory activities.
• Experience mentoring, training, or providing guidance to less experienced team members preferred.
• Experience with a Clinical Trial Management System (CTMS), electronic regulatory platform, eSource, or other clinical research technology preferred.