Regulatory Specialist

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

📋 Description

• Assist in the preparation and submission of regulatory documents to IRBs, sponsors, and internal stakeholders, which includes initial submissions, amendments, continuing reviews, and safety reports.

• Maintain and refresh Investigator Site Files (ISFs), regulatory binders, and electronic systems to ensure that all documents are up-to-date and accurately filed.

• Aid in the coordination of the collection and submission of start-up documents such as site questionnaires, training logs, CVs, and delegation logs.

• Ensure that all documentation adheres to ICH-GCP, FDA regulations, and specific requirements set by sponsors.

• Act as a liaison among research staff, investigators, sponsors, and IRBs to ensure regulatory processes are completed accurately and on time.

• Keep regulatory files prepared for audits and assist with the preparation and support during monitoring visits, sponsor audits, or inspections.

• Participate in regulatory meetings, take minutes as necessary, and provide updates regarding document status and submission timelines.

• Monitor expiration dates for approvals, licenses, and other time-sensitive documents; assist with maintaining regulatory logs and tracking tools.

⛳️ Requirements

• A bachelor’s degree is preferred, ideally in life sciences, healthcare, or a related discipline.

• A minimum of 1–3 years of experience in clinical research or regulatory affairs is required.

• Exceptional organizational skills and a keen attention to detail are essential.

• Ability to juggle multiple deadlines and prioritize tasks effectively.

• Strong written and verbal communication skills are necessary.

🏝️ Benefits

• Professionalism in interactions with both internal and external stakeholders.

• Proficiency in Microsoft Office Suite and regulatory document platforms (e.g., CRIO, Complion, Veeva).