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Regulatory Specialist
Prolerity Clinical Research. Prepare and submit regulatory documents to IRBs, sponsors, and internal stakeholders, including initial submissions, amendments, continuing reviews, and safety reports .
About the role
Key responsibilities & impact- Prepare and submit regulatory documents to IRBs, sponsors, and internal stakeholders, including 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 collection and submission of study start-up documents, including site questionnaires, training logs, CVs, and delegation logs
- Ensure documentation complies with ICH-GCP, FDA regulations, and sponsor-specific requirements
- Liaise with research staff, investigators, sponsors, and IRBs to facilitate regulatory processes
- Keep regulatory files audit-ready and assist with monitoring visits, sponsor audits, and 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 as needed to support the research program and organizational needs
Requirements
What you’ll need- 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, including CRIO, Complion, and Veeva
- At least 1–3 years of experience in clinical research or regulatory affairs
- Bachelor’s degree preferred, ideally in life sciences, healthcare, or a related field
- Experience submitting documents to IRBs and maintaining regulatory binders in a clinical trial environment is preferred