Regulatory Specialist

About the role

The Regulatory Specialist coordinates and maintains all regulatory documentation, ensuring compliance with applicable guidelines, institutional policies, and sponsor requirements. This role supports study start-up, submissions, and ongoing documentation throughout the lifecycle of clinical trials, working closely with the Regulatory Manager, clinical teams, and sponsors to ensure regulatory materials are accurate, complete, and audit-ready.

Responsibilities

• Assist in preparing and submitting regulatory documents to IRBs, sponsors, and internal stakeholders, including initial submissions, amendments, continuing reviews, and safety reports.
• 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.
• Help coordinate collection and submission of start-up documents such as site questionnaires, training logs, CVs, and delegation logs.
• Ensure documentation complies with ICH-GCP, FDA regulations, and sponsor-specific requirements.
• Serve as a liaison between research staff, investigators, sponsors, and IRBs to facilitate timely and accurate regulatory processes.
• Keep regulatory files audit-ready and assist with preparation and support during monitoring visits, sponsor audits, or inspections.
• Attend regulatory meetings, take minutes as needed, and provide updates on document status and submission timelines.
• Track expiration dates for approvals, licenses, and other time-sensitive documents; assist with regulatory logs and tracking tools.
• Perform additional duties and tasks as assigned to support the research program or organizational needs, which may evolve over time.

Requirements

• 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).

Qualifications

• Bachelor’s degree preferred, ideally in life sciences, healthcare, or a related field.
• At least 1–3 years of experience in clinical research or regulatory affairs.
• Experience submitting documents to IRBs and maintaining regulatory binders in a clinical trial environment (preferred).