We are seeking a detail-oriented and highly organized Nonclinical Regulatory Documentation Specialist to support quality control and submission readiness of nonclinical regulatory documents. This role will contribute to DMPK and Toxicology reporting, regulatory submission modules, and document lifecycle management in a fast-paced, compliance-driven environment.Key ResponsibilitiesPerform quality control (QC) review of nonclinical content for DMPK and Toxicology reports, as well as regulatory submission documents including Module 2 and Module 4.Provide editorial support, including document editing, formatting, and preparation of submission-ready Word and PDF files in accordance with internal style guides and global regulatory requirements.Support Veeva activities related to nonclinical regulatory document lifecycle management, including document routing, version control, and archival.Assist with literature reference-related activities, including reference retrieval, copyright clearance review, and upload to electronic document management systems.Independently identify and resolve issues, exercising sound judgment, effective communication, and flexibility within a dynamic, cross-functional environment.
