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

Mount Sinai Health System•New York, NY

About The Position

The Director of Regulatory & Administrative Affairs for the Mount Sinai Institute for Transformative Clinical Trials provides strategic leadership and operational oversight for regulatory, safety, and administrative activities across sponsor-led, investigator-initiated, federally funded, and industry-sponsored clinical research studies. Working within an Academic CRO and Data and Clinical Coordinating Center environment, the Director oversees regulatory activities for domestic and international multicenter clinical trials conducted across participating research institutions and supports participating sites throughout the study lifecycle. The role leads regulatory affairs and safety operations, including FDA, Health Canada, and Institutional Review Board submissions and oversight. The Director also supports clinical trial safety operations and oversight committees, develops compliant policies and procedures, and leads, trains, and mentors regulatory, safety, and administrative personnel.

Requirements

Bachelor's degree in Administration or a related field.
At least seven years of progressively responsible experience in clinical research regulatory affairs supporting multicenter clinical research studies.
At least three years of leadership experience managing personnel in regulatory affairs and safety operations.
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, Health Canada, and other regulatory bodies as required.
Excellent leadership, organizational, interpersonal, and communication skills, including the ability to collaborate with investigators, sponsors, regulatory authorities, participating institutions, oversight committees, and multidisciplinary teams.
Ability to manage multiple studies and competing deadlines in a fast-paced environment.
Exceptional attention to detail and documentation practices.
Proficiency with Microsoft Office applications, version control of critical documents, and electronic regulatory management systems.

Nice To Haves

Master's degree or higher in Life Sciences, Regulatory Affairs, Health Administration, or a related field, or a bachelor's degree with equivalent experience.
Previous experience in IRB work.
IRB certification.
Regulatory Affairs Certification (RAC) or Certified Clinical Research Professional (CCRP/CCRC) certification.
Knowledge of the European Union Clinical Trials Regulation, GDPR, and 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.

Responsibilities

Provide strategic leadership for regulatory activities supporting multicenter clinical trials.
Ensure sponsor and participating-site compliance with FDA regulations, ICH-GCP guidelines, human subjects protection requirements, institutional policies, sponsor obligations, and applicable international regulatory requirements.
Ensure compliance with applicable international privacy and data protection requirements, including GDPR and related regulations.
Develop and implement regulatory policies, procedures, and operational processes, including regulatory document and binder templates, Manuals of Procedures, and SOPs.
Prepare and submit study applications, amendments, continuing reviews, reportable safety events, and study closures to the FDA, Health Canada, and Institutional Review Boards.
Monitor regulatory deadlines and reporting requirements at the coordinating center and study-site levels.
Develop and maintain regulatory binders, oversee site regulatory binders, and maintain essential study documents, including the electronic Trial Master File.
Create and review informed consent templates and recruitment materials for regulatory compliance and consistency with protocol requirements.
Track protocol amendments, investigator qualifications, training records, and regulatory approvals for the coordinating center and participating-site staff.
Support study start-up, staff and study-team training, site activation, audits, and inspections.
Assist with responses to regulatory findings and audit observations, and with corrective and preventive action plans.
Ensure readiness for sponsor audits, quality assurance reviews, and regulatory inspections.
Direct, train, and mentor regulatory, safety, and administrative personnel.
Lead and oversee clinical trial safety operations, including expedited safety reporting and other regulatory safety requirements.
Oversee safety desk operations and 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, Clinical Event Adjudication Committees, Independent Medical Monitors, and other required parties.