Director, Regulatory & Administrative Affairs - Institute for Transformative Clinical Trials

Responsibilities

• Provide strategic leadership including development and oversight of regulatory activities supporting multicenter clinical trials
• Ensure sponsor and multi-center site compliance with FDA regulations, ICH-GCP guidelines, human subjects protection requirements, institutional policies, sponsor obligations, and applicable international regulatory requirements including Canada, the United Kingdom, and the European Union for IND, IDE, and non-FDA regulated clinical trials
• Develop and implement regulatory policies, procedures, and operational processes that support compliant and efficient research operations including creation of regulatory document and binder templates, Manuals of Procedures (MOPs) and SOPs
• Prepare and submit new study applications (IND/IDE), amendments, continuing reviews, reportable safety events, and study closures to the FDA, HC, and Institutional Review Boards
• Monitor regulatory deadlines and reporting requirements to ensure ongoing compliance at both the DCC/CCC and study site level
• Create and review informed consent document templates and recruitment materials for regulatory compliance and consistency with protocol requirements
• Track protocol amendments, investigator qualifications, training records, and regulatory approvals for the DCC/CCC and the study staff at participating sites
• Aid with responses to regulatory findings, audit observations, and corrective and preventive action (CAPA) plans when needed
• Ensure ongoing readiness for sponsor audits, quality assurance reviews, and regulatory inspections
• Direct, train, and mentor regulatory, safety, and administrative personnel

Safety Operations & Oversight

• Provide leadership and oversight for clinical trial safety operations, including expedited safety reporting, and other regulatory safety requirements for IND/IDE/non-FDA regulated clinical trials
• Oversee safety desk operations and ensure timely communication of safety information to investigators, sponsors, IRBs, DSMBs, regulatory authorities, and participating sites
• Oversee operational and regulatory support for Data and Safety Monitoring Boards (DSMBs), Clinical Event Adjudication Committees (CEC/EACs), Independent Medical Monitors, and other required parties

Qualifications

• Bachelor's Degree in Administration, or related field
• Masters preferred
• Seven (7) years experience in administration
• Previous experience in IRB
• Preferred Advanced degree (Master's or higher) in Life Sciences, Regulatory Affairs, Health Administration, or a related field or Bachelor's degree with equivalent experience
• Minimum of three (3) years of leadership experience managing regulatory affairs and safety operations related personnel
• Demonstrated experience supporting FDA-regulated clinical trials, including IND and/or IDE studies
• Strong knowledge of FDA regulations, ICH-GCP guidelines, human subjects protections, informed consent requirements, IRB processes, and clinical trial regulatory documentation and compliance requirements
• Experience with applicable submissions to the FDA, IRB, HC, and other regulatory bodies as required
• Excellent leadership, organizational, interpersonal and communication skills supporting collaboration with investigators, sponsors, regulatory authorities, participating institutions, oversight committees, and multidisciplinary teams
• Exceptional attention to detail and documentation practices
• Proficiency with Microsoft Office applications, version control of critical documents, and electronic regulatory management systems
• Regulatory Affairs Certification (RAC) or Certified Clinical Research Professional (CCRP/CCRC) certification
• Knowledge of European Union Clinical Trials Regulation (CTR), GDPR, United Kingdom data protection requirements
• Experience supporting multicenter clinical research networks, or similar coordinating center environments in a CRO, ARO, or sponsor environment
• Experience with FDA inspections and sponsor audits