Regulatory Submissions Specialist

Role: Regulatory Submissions Specialist responsible for preparing, processing, and submitting regulatory documentation for IND, CTA, BLA, and related filings to US, CA, and international agencies. Responsibilities: assemble, format, quality check, publish, archive submissions using electronic publishing tools (eCTD Manager, Adobe Acrobat, Veeva RIMS), ensure compliance with regional regulations, provide regulatory guidance on documentation, troubleshoot system issues, and optimize submission workflows. Requirements: minimum 1 year of regulatory electronic publishing experience, familiarity with IND, CTA, BLA submissions, eCTD and ESG electronic submission experience, proficiency in MS Word and EndNotes, strong attention to detail, analytical skills, and ability to manage multiple tasks in a fast-paced environment. Preferred: experience with clinical trial documentation and validation of publishing systems. High-Value: focus on electronic publishing for regulatory submissions, experience with global health authority filings, including IMPDs and Briefing Documents, knowledge of regulatory compliance and document control systems. Work Setup: not specified.