Regulatory Specialist

Job Description

The Regulatory Specialist is responsible for coordinating and maintaining all regulatory documentation and ensuring compliance with applicable guidelines, institutional policies, and sponsor requirements. This role plays a key part in supporting study start-up, submissions, and ongoing documentation throughout the lifecycle of clinical trials.

Working closely with the Regulatory Manager, clinical teams, and sponsors, the Regulatory Specialist ensures that all regulatory materials are accurate, complete, and audit-ready.

Key Responsibilities:

• Document Preparation & Submission: Assist in preparing and submitting regulatory documents to IRBs, sponsors, and internal stakeholders including initial submissions, amendments, continuing reviews, and safety reports.
• Regulatory File Maintenance: Maintain and update Investigator Site Files (ISFs), regulatory binders, and electronic systems (e.g., CRIO, Veeva, Complion) to ensure documents are current and properly filed.
• Study Start-Up Support: Help coordinate collection and submission of start-up documents such as site questionnaires, training logs, CVs, and delegation logs.
• Compliance Monitoring: Ensure documentation complies with ICH-GCP, FDA regulations, and sponsor-specific requirements.
• Communication: Serve as a liaison between research staff, investigators, sponsors, and IRBs to facilitate timely and accurate regulatory processes.
• Audit Readiness: Keep regulatory files audit-ready and assist with preparation and support during monitoring visits, sponsor audits, or inspections.
• Meeting Participation: Attend regulatory meetings, take minutes as needed, and provide updates on document status and submission timelines.
• Tracking & Reporting: Track expiration dates for approvals, licenses, and other time-sensitive documents; assist with regulatory logs and tracking tools.

Additional Responsibilities:

This job description is intended to outline the primary responsibilities of the Regulatory Specialist; however, additional duties and tasks may be assigned as needed to support the research program or the needs of the organization. These responsibilities may evolve over time based on the requirements of new studies or operational needs.

Requirements

Knowledge, Skills, and Abilities:

• Familiarity with FDA, ICH-GCP, and IRB regulatory requirements
• Excellent organizational skills and attention to detail
• Ability to manage multiple deadlines and prioritize tasks
• Strong written and verbal communication skills
• Professionalism when interacting with internal and external stakeholders
• Proficiency in Microsoft Office Suite and regulatory document platforms (e.g., CRIO, Complion, Veeva)

Required Experience and Qualifications:

• Education: Bachelor's degree preferred, ideally in life sciences, healthcare, or a related field
• Experience: At least 1-3 years of experience in clinical research or regulatory affairs
• Preferred Qualifications: Experience submitting documents to IRBs and maintaining regulatory binders in a clinical trial environment