Regulatory Specialist

About This Opportunity

Our talent team is representing a confidential clinical research organization seeking a Regulatory Specialist to join their operations in the United States. This role offers the chance to support regulatory compliance for clinical trials across multiple therapeutic areas, working with sponsors, CROs, and ethics committees to ensure study documentation meets all applicable regulatory standards.

As a recruiter working with this client, we're looking for someone who thrives in a detail-oriented environment and can manage multiple regulatory submissions while maintaining accuracy and timeliness. You'll be instrumental in supporting site staff and ensuring all regulatory documents are complete and submission-ready.

Responsibilities

• Prepare and submit all required regulatory documents for study start-up and ongoing maintenance with attention to accuracy and deadlines
• Serve as the liaison between 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 documentation
• Track expiration dates and proactively update required documents to maintain compliance
• Support site staff and Clinical Research Coordinators with documentation requests, continuing review, and study close-out submissions
• Coordinate with internal teams including Budgets & Contracts, Business Development, and Recruitment to support study start-up activities
• Manage distribution, tracking, and archiving of essential documents requiring signatures
• Assist with feasibility tracking and provide regulatory metrics to sponsors and senior management
• Ensure audit and inspection readiness by maintaining accurate and complete documentation

What We're Looking For

• 1–3 years of clinical research experience, preferably in regulatory or quality assurance roles
• Solid understanding of ICH/GCP, FDA, Health Canada, and ethics committee requirements
• Highly organized with proven ability to manage multiple priorities while meeting strict deadlines
• Clear and effective communication skills for working with internal teams, sponsors, CROs, and regulatory bodies
• Detail-oriented and proactive approach to identifying and resolving documentation or compliance issues
• Ability to work independently as well as collaboratively in a fast-paced environment
• Experience with CTMS, EDC, or other document management systems
• Strong initiative and follow-through with accountability for results

How We Work With You

When you apply through Get A Job.ai, our recruiting team will review your qualifications and conduct an initial screening. If your background aligns with what our client is seeking, we will submit your profile to them for consideration. Please note that all applications must come through Get A Job.ai—do not attempt to contact the client directly, as we are managing this search exclusively.

Our team will keep you informed throughout the process and coordinate all interviews and next steps on your behalf.

Pay

Compensation details will be discussed during the screening process based on your experience and qualifications.

Equal Opportunity

Get A Job.ai is an equal opportunity recruiter. We welcome applicants from all backgrounds and are committed to building diverse candidate pools for our clients.