Regulatory Compliance Manager

About the role

The Regulatory Compliance Manager will support the Executive Director for the Center of Excellence for Clinical & Translational Research in the planning, execution, and coordination of regulatory activities associated with clinical research projects conducted by the Organization.

Responsibilities

• Prepare, compile, maintain, and support submissions related to INDs, IDEs, protocol amendments, continuing reviews, annual reports, safety reports, and other regulatory filings under the guidance of The Executive Director for the Center of Excellence for Clinical & Translational Research.
• Maintain regulatory binders, electronic regulatory files, investigator/site regulatory records, and essential documents, including investigator qualifications, training records, financial disclosures, delegation logs, laboratory certifications, and other required documentation in accordance with ICH-GCP and organizational SOPs.
• Review regulatory documents for completeness, consistency, and accuracy, and collaborate with project team members to ensure submission requirements are met.
• Serve as a regulatory contact for study sponsors, IRBs, regulatory agencies, and other oversight bodies, as applicable.
• Support IRB submissions, continuing reviews, amendments, reportable events, and study closure activities.
• Monitor updates from the FDA, Office for Human Research Protections (OHRP), IRBs, ClinicalTrials.gov, and other applicable regulatory authorities to ensure ongoing compliance with current regulations, guidance documents, and industry standards.
• Support clinical trial registration and results reporting activities in ClinicalTrials.gov, as applicable.
• Support communications and submissions to the FDA under the direction of Regulatory Affairs leadership when required.
• Provide guidance and support to study teams regarding regulatory requirements, processes, and documentation.
• Identify project needs, track timelines, and manage day-to-day workload in collaboration with the Executive Director for the Center of Excellence for Clinical & Translational Research.
• Provide regulatory support to the Safety Team and assist with the preparation, tracking, and submission of serious adverse event reports, safety reports, and other pharmacovigilance-related documentation in accordance with organizational SOPs and sponsor requirements.
• Assist with preparation for sponsor, regulatory authority, and internal audits and inspections, including documentation review and response activities.
• Follow organizational SOPs and procedural documents consistently and contribute to process improvement initiatives.
• Perform other duties as assigned.

Requirements

• Bachelor's degree in life sciences, health sciences, nursing, pharmacy, public health, regulatory affairs, or related field required.
• Current certification in Good Clinical Practice (GCP) training (or ability to obtain within 90 days of hire).
• Current Human Subjects Protection (HSP) training (e.g., CITI Program or equivalent) or ability to obtain within 90 days of hire.
• Must maintain all required institutional, sponsor, and regulatory training throughout employment.

Qualifications

• Advanced degree (MS, MPH, PharmD