Regulatory Specialist

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

📋 Description

• Prepare and submit regulatory documents to Institutional Review Boards (IRBs), sponsors, and internal stakeholders, which includes initial submissions, amendments, continuing reviews, and safety reports.

• Maintain and update Investigator Site Files, regulatory binders, and electronic systems such as CRIO, Veeva, and Complion.

• Coordinate the collection and submission of study start-up documents, including site questionnaires, training logs, CVs, and delegation logs.

• Ensure that documentation adheres to ICH-GCP, FDA regulations, and specific sponsor requirements.

• Serve as a liaison with research staff, investigators, sponsors, and IRBs to streamline regulatory processes.

• Keep regulatory files ready for audits and assist with monitoring visits, sponsor audits, and inspections.

• Attend regulatory meetings, take minutes as needed, and provide updates on the status of documents and submission timelines.

• Track expiration dates for approvals, licenses, and other documents that are time-sensitive.

• Assist with regulatory logs and tracking tools.

• Perform additional duties as required to support the research program and meet organizational needs.

⛳️ Requirements

• Knowledge of FDA, ICH-GCP, and IRB regulatory requirements.

• Exceptional organizational skills and keen attention to detail.

• Capability to manage multiple deadlines and effectively prioritize tasks.

• Strong written and verbal communication skills.

• Professional demeanor when engaging with both internal and external stakeholders.

• Proficiency in Microsoft Office Suite and regulatory document platforms, including CRIO, Complion, and Veeva.

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

• Bachelor’s degree preferred, ideally in life sciences, healthcare, or a related field.

• Preferred experience in submitting documents to IRBs and maintaining regulatory binders within a clinical trial setting.

🏝️ Benefits

• Opportunity for professional development and growth within the organization.

• Collaborative work environment that values innovation and teamwork.

• Competitive salary and comprehensive benefits package.