Regulatory Specialist

Centricity Research

About The Position

We’re looking for a detail-oriented and proactive Regulatory Specialist to support the regulatory operations of our clinical trials. You’ll play a critical role in ensuring that all regulatory documents are accurate, complete, and submitted on time, helping our sites execute studies efficiently and in compliance with FDA, Health Canada, and other applicable regulations. As a Regulatory Specialist, you’ll work closely with internal teams, sponsors, CROs, and ethics committees to facilitate study start-up and ongoing compliance, supporting both site staff and leadership with regulatory documentation and processes.

Requirements

1–3 years of clinical research experience, preferably in regulatory or quality assurance.
A solid understanding of ICH/GCP, FDA, Health Canada, and ethics committee requirements.
Highly organized and able to manage multiple priorities while meeting deadlines.
Communicate clearly and effectively with internal teams, sponsors, CROs, and regulatory bodies.
Detail-oriented and proactive in identifying and resolving documentation or compliance issues.
Comfortable working independently as well as collaboratively in a fast-paced environment.
Experience with CTMS, EDC, or other document management systems.

Responsibilities

Prepare and submit all required regulatory documents for study start-up and ongoing maintenance, ensuring accuracy and timeliness.
Liaise with sponsors, CROs, and ethics committees (REB/IRB) to facilitate prompt review and approval of study documents.
Maintain central regulatory files, including CVs, licenses, certifications, and other essential documents.
Track expiration dates and maintain proactive updates for required documents.
Support site staff and Clinical Research Coordinators with documentation requests, continuing review, and study close-out submissions.
Coordinate with internal teams (Budgets & Contracts, Business Development, Recruitment) to support study start-up activities and recruitment material submissions.
Serve as the gatekeeper for essential documents requiring signatures; manage distribution, tracking, and archiving.
Assist with feasibility tracking and provide metrics to sponsors and senior management.
Ensure readiness for audits and inspections by maintaining accurate and complete documentation.