Senior Specialist, Regulatory Operations

Responsibilities: The Senior Specialist, Regulatory Operations will oversee and execute all site-level regulatory operational activities for assigned clinical trials in the U.S. This role includes ensuring compliance with applicable U.S. regulations and guidelines and supporting regulatory activities for Canadian sites as needed.

Requirements: Candidates should have a minimum of 4 years of experience in operational regulatory affairs within the research site or CRO/pharmaceutical industry, focusing on U.S. regulatory requirements. A bachelor's degree in a scientific or healthcare-related field is required, with an advanced degree preferred.

Key skills: Regulatory Compliance, Clinical Trials, FDA Regulations, IRB Submissions, Project Management, Communication Skills, Team Collaboration, Problem Solving, Attention to Detail, Strategic Planning, Risk Management, Change Management, Regulatory Affairs, Documentation Management, Training, Data Tracking

Keywords: Regulatory Operations, Clinical Trials, FDA, OHRP, IRB, Good Clinical Practice, Essential Records, Site Evaluation Visit, Site Initiation Visit, Study Closeout, Delegation of Authority, Safety Reports, Investigator Site File, Regulatory Intelligence, Standard Operating Procedures, Clinical Operations, Health Services, Research, Community Health, Medical Breakthroughs, Compliance, Documentation, Monitoring, Audits, Training, Collaboration, Process Improvement, Technology, Health Screenings, Diversity and Inclusion