Regulatory Specialist

Centricity Research; Toronto; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading clinical research network is hiring a Regulatory Specialist in Toronto, Ontario. This full-time role involves preparing and submitting regulatory documents essential for clinical trials, ensuring compliance with regulations. Candidates should have 1-3 years of clinical research experience, strong organizational skills, and familiarity with ICH/GCP and FDA requirements. The role offers an opportunity to contribute to efficient trial processes and facilitate collaboration among various stakeholders. Join a mission-driven team dedicated to advancing scientific research while maintaining a focus on quality and care.

Qualifications

• 1–3 years of clinical research experience, preferably in regulatory or quality assurance.
• Solid understanding of regulatory requirements.
• Highly organized and adept at managing priorities.

Responsibilities

• Prepare and submit regulatory documents for studies.
• Liaise with sponsors and ethics committees.
• Maintain regulatory files and track document updates.
• Support staff with documentation requests and studies.
• Coordinate with internal teams on start-up activities.
• Manage essential document signatures and tracking.
• Ensure readiness for audits and inspections.

Skills

Clinical research experience

Understanding of ICH/GCP and FDA regulations

Organizational skills

Clear communication

Attention to detail

Proactive problem solving

Experience with document management systems

Tools

CTMS

EDC

Job description

Join Us at Centricity Research!

Centricity Research is one of the largest clinical research networks in North America. We are a fully centralized Integrated Research Organization (IRO) specializing in conducting Phase I‑IV clinical trials in over 35 therapeutic areas: inpatient and outpatient; pharmaceutical, biotechnology, and medical device trials.

About The Role

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.

This is a full-time temporary role.

What You’ll Do

• 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.

You Might Be a Great Fit If You

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

Why Centricity Research?

Our Mission

We connect people to scientific advancements through groundbreaking research within a deeply human experience.

Our Core Values

• Quality: We aim for excellence and integrity in everything we do - because lives depend on it.
• Care: We show up for each other, our customers, and our mission - always going the extra mile.
• Be the Change You Seek: We're adaptable, forward‑thinking, and constantly improving - for the betterment of all.
• One Team: We collaborate, support one another, and succeed together.
• Grow for Good: We grow with purpose - to expand access to research and improve global health.
• Own It: We take initiative, deliver results, and follow through - with passion and accountability.

Ready to Apply?

We’d love to hear from you – apply now!

We’re an equal opportunity employer committed to building a diverse and inclusive workplace. We welcome applicants from all backgrounds and will provide accommodations during the hiring process upon request.