Senior Regulatory Operations Specialist

Job Summary

To support regulatory compliance efforts, the full-time Senior Regulatory Operations Specialist will manage the planning, preparation, and submission of regulatory documents to global health authorities, focusing on U.S. FDA electronic submissions while working remotely.

Key responsibilities

• Provide detailed review of data and reports for regulatory submissions to ensure scientific accuracy
• Prepare and compile regulatory submissions, ensuring compliance with health authority regulations and company policies
• Manage submission workflows within Veeva Vault RIM and track deliverables to ensure timely submissions

Required qualifications

• Bachelor's degree and 2-3 years of directly related experience in Regulatory Operations
• Experience with preparing and submitting eCTD submissions (INDs, NDAs, BLAs) to FDA or global agencies
• Strong understanding of ICH, FDA, and regional electronic submission standards
• Experience with Veeva Vault RIM or equivalent Regulatory Information Management Systems
• Proficiency in Microsoft Word, Adobe, Excel, and PowerPoint