Regulatory Specialist

Join the Centricity Research Team! Centricity Research is one of North America's largest clinical research networks and a fully centralized Integrated Research Organization (IRO). We conduct Phase I-IV clinical trials across more than 35 therapeutic areas, partnering with leading pharmaceutical, biotechnology, and medical device companies to advance healthcare through innovative clinical research. Join our growing team and build a rewarding career while helping bring new treatments to patients. About the Role We’relooking for a detail-oriented and proactive Regulatory Specialist to support the regulatory operations of our clinical trials.You’llplay a critical role in ensuring that all regulatory documents areaccurate, 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’llwork closely with internal teams, sponsors, CROs, and ethics committees tofacilitatestudy start-up and ongoing compliance, supporting both site staff and leadership with regulatory documentation and processes. What You’ll Do Prepare andsubmitall required regulatory documents for study start-up and ongoing maintenance, ensuring accuracy and timeliness. Liaise with sponsors, CROs, and ethics committees (REB/IRB) tofacilitateprompt review and approval of study documents. Maintain central regulatory files, including CVs, licenses, certifications, and other essential documents. Trackexpirationdates andmaintainproactive updates for required documents. Support site staff and Clinical Research Coordinators with documentation requests, continuing review,and studyclose-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. Assistwith 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. Arehighly 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 inidentifyingand 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 adeeplyhuman 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'readaptable, 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 andimproveglobal 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’dlove to hear from you – apply now! We’rean equal opportunity employer committed to building a diverse and inclusive workplace. We welcome applicants from all backgrounds and will provideaccommodationsduring the hiring process upon request. Originally posted on Himalayas