Regulatory Specialist

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. 

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. 

Benefits 

• Comprehensive health, dental, and vision insurance 

• Enhanced EAP – mental health support 

• Flexible PTO + paid holidays 

• Continuing education reimbursement 

• 401(k) / RRSP with company match and immediate vesting 

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.