Regulatory Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Prepare and submit necessary regulatory documents for the initiation and ongoing management of studies.

• Collaborate with sponsors, CROs, and ethics committees (REB/IRB) to ensure timely review and approval of study documentation.

• Maintain centralized regulatory files, including CVs, licenses, certifications, and other critical documents.

• Monitor expiration dates and proactively update required documentation.

• Assist site staff and Clinical Research Coordinators with requests for documentation, ongoing reviews, and submissions for study close-out.

• Coordinate with the Budgets & Contracts, Business Development, and Recruitment teams regarding study initiation and the submission of recruitment materials.

• Oversee essential documents that require signatures, including their distribution, tracking, and archiving.

• Support feasibility tracking and provide metrics to sponsors and senior management.

• Ensure accurate and complete documentation is maintained for audit and inspection readiness.

⛳️ Requirements

• 1–3 years of experience in clinical research, with a preference for regulatory or quality assurance roles.

• Strong understanding of ICH/GCP, FDA, Health Canada, and ethics committee regulations.

• Highly organized with the ability to manage multiple priorities while adhering to deadlines.

• Excellent communication skills for effective interaction with internal teams, sponsors, CROs, and regulatory agencies.

• Detail-oriented and proactive in identifying and resolving documentation or compliance challenges.

• Comfortable working both independently and collaboratively in a dynamic environment.

• Familiarity with CTMS, EDC, or other document management systems.

🏝️ Benefits

• Comprehensive health, dental, and vision insurance.

• Enhanced Employee Assistance Program (EAP) offering mental health support.

• Flexible Paid Time Off (PTO) plus paid holidays.

• Continuing education reimbursement.

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