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

Mount Sinai Health Systems•New York, NY

5d•$95,450 - $143,175

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 supporting sponsor-led, investigator-initiated, federally funded, and industry-sponsored clinical research studies. Working in an Academic CRO and Data and Clinical Coordinating Center environment, the Director oversees regulatory affairs and safety operations throughout the study lifecycle and supports participating sites in domestic and international multicenter research networks. The role includes oversight of studies conducted across participating research institutions and requires experience with FDA and Health Canada submissions, including IND and IDE applications, IRB submissions, and regulatory oversight of multicenter human subjects research.

Requirements

Bachelor's degree in Administration or a related field; a master's degree is preferred.
At least 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 subjects protections, informed consent requirements, IRB processes, and clinical trial regulatory documentation and compliance requirements.
Experience with applicable 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 oversee regulatory activities supporting multicenter clinical trials.
Ensure sponsor and site compliance with FDA regulations, ICH-GCP guidelines, human subjects protection requirements, institutional policies, sponsor obligations, and applicable international requirements, including those in Canada, the United Kingdom, and the European Union.
Ensure compliance with 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 new 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 DCC/CCC and study-site levels.
Develop and maintain regulatory binders, including oversight of site binders, and essential study documents such as the 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 DCC/CCC and participating-site study 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.
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 DSMBs, Clinical Event Adjudication Committees, Independent Medical Monitors, and other required parties.