Regulatory Assistant
Sweet Hope Research Specialty Inc
Behavioral Health Market Context
Apply Nowvia BeBee
Qualifications
- •Basic understanding of ICH-GCP, FDA regulations, and clinical trial processes
- •Strong organizational and documentation skills
- •High attention to detail and accuracy
- •Ability to manage multiple tasks and deadlines in a fast-paced environment
- •1 more items(s)
Responsibilities
- •The Regulatory Affairs Specialist Assistant supports the regulatory operations of the clinical research site by ensuring timely, accurate, and compliant preparation, submission, and maintenance of regulatory documentation
- •This role assists in maintaining adherence to ICH-GCP guidelines, FDA regulations, IRB requirements, and sponsor protocols, while contributing to audit readiness and overall site quality
- •Assist in the preparation, review, and organization of regulatory documents (e.g., 1572s, CVs, medical licenses, training records)
- •Maintain and update electronic regulatory systems (eReg) and ensure completeness of regulatory binders
- •Track document expirations and ensure timely updates (licenses, GCP training, certifications)
- •Assist in ensuring site compliance with FDA, ICH-GCP, and sponsor requirements
- •Support internal audits, sponsor audits, and regulatory inspections by preparing and organizing documentation
- •Participate in quality control (QC) checks of regulatory files
- •5 more items(s)
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