Job Title: Regulatory Specialist

Work Location: Remote

Summary:

The Regulatory Specialist is responsible for managing regulatory documentation and ensuring compliance with relevant guidelines and policies throughout the lifecycle of clinical trials. This role supports study start-up, submissions, and ongoing documentation, working closely with clinical teams and other stakeholders to maintain accurate and audit-ready regulatory materials.

Responsibilities:

• Prepare and submit regulatory documents for review, including initial submissions, amendments, continuing reviews, and safety reports.
• Maintain and update regulatory files, binders, and electronic systems to ensure all documents are current and properly organized.
• Coordinate the collection and submission of study start-up documents such as site questionnaires, training logs, CVs, and delegation logs.
• Monitor compliance with ICH-GCP, FDA regulations, and other applicable requirements for all regulatory documentation.
• Act as a liaison between research staff, investigators, sponsors, and review boards to facilitate regulatory processes.
• Ensure regulatory files are audit-ready and assist with preparation and support during monitoring visits, audits, or inspections.
• Participate in 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, and assist with maintaining regulatory logs and tracking tools.

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 review boards and maintaining regulatory binders in a clinical trial environment preferred.
• Familiarity with FDA, ICH-GCP, and review board regulatory requirements.
• Excellent organizational skills and attention to detail.
• Ability to manage multiple deadlines and prioritize tasks effectively.
• Strong written and verbal communication skills.
• Professionalism in interactions with internal and external stakeholders.
• Proficiency in Microsoft Office Suite and regulatory document platforms (such as CRIO, Complion, Veeva).

Published Category: Regulatory Affairs