We are seeking a detail-oriented and highly organized Nonclinical Regulatory Documentation Specialist to support the quality control, preparation, and management of nonclinical regulatory documents. This role plays a critical part in ensuring submission readiness for DMPK and Toxicology reports, contributing to global regulatory filings in a fast-paced, compliance-driven environment.Key ResponsibilitiesPerform quality control (QC) review of nonclinical documents, including DMPK and Toxicology reports, as well as regulatory submission content (e.g., Module 2 and Module 4).Provide editorial and formatting support to ensure documents meet internal standards and global regulatory requirements.Prepare and finalize submission-ready Word and PDF documents.Support Veeva-based document lifecycle management, including routing, version control, and archival.Manage reference-related activities, including literature retrieval, copyright review, and upload into document management systems.Identify and resolve documentation issues independently, demonstrating strong judgment and proactive communication.Collaborate cross-functionally with scientific and regulatory teams to ensure accuracy, consistency, and compliance.
