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. In an Academic CRO and Data and Clinical Coordinating Center environment, the role oversees regulatory affairs for domestic and international multicenter trials and supports participating sites throughout the study lifecycle. The Director leads regulatory affairs and safety operations, ensuring compliance with FDA regulations, ICH-GCP guidelines, human-subject protection requirements, institutional policies, sponsor obligations, and applicable international requirements. The role develops and oversees regulatory processes and documentation; prepares and submits regulatory applications and reports; monitors deadlines; supports study startup, training, site activation, audits, and inspections; and directs regulatory, safety, and administrative personnel. It also provides leadership for safety operations and operational and regulatory support to oversight committees and independent monitors.

Requirements

Bachelor’s degree in administration or a related field; a master’s degree is preferred.
Seven years of experience in administration.
Previous IRB experience.
Minimum of seven years of progressively responsible experience in clinical research regulatory affairs supporting multicenter clinical research studies.
Minimum of three years of leadership experience managing regulatory-affairs and safety-operations personnel.
Demonstrated experience supporting FDA-regulated clinical trials, including IND and/or IDE studies.
Strong knowledge of FDA regulations, ICH-GCP guidelines, human-subject protections, informed-consent requirements, IRB processes, and clinical-trial regulatory documentation and compliance requirements.
Experience with submissions to the FDA, IRBs, Health Canada, and other regulatory bodies as required.
Excellent leadership, organizational, interpersonal, and communication skills for collaboration 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

IRB certification.
Advanced degree (master’s or higher) in life sciences, regulatory affairs, health administration, or a related field, or a bachelor’s degree with equivalent experience.
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 and oversight for regulatory activities supporting multicenter clinical trials.
Ensure sponsor and participating-site compliance with FDA regulations, ICH-GCP guidelines, human-subject protection requirements, institutional policies, sponsor obligations, and applicable international regulations.
Ensure compliance with international privacy and data-protection requirements, including GDPR and related regulations.
Develop and implement regulatory policies, procedures, and 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 startup, 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 when needed.
Maintain readiness for sponsor audits, quality-assurance reviews, and regulatory inspections.
Direct, train, and mentor regulatory, safety, and administrative personnel.
Provide leadership and oversight for 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.