Manager of Regulatory Operations
Job Summary
Managing day-to-day regulatory submission operations, the full-time Manager of Regulatory Operations will ensure high-quality, timely, and compliant health authority submissions while working remotely.
Key responsibilities
- Oversee the formatting and generation of submission-ready PDFs in compliance with regulatory guidance and internal standards
- Coordinate submission execution activities, including tracking deliverables and communicating with cross-functional stakeholders
- Perform technical quality control of submission documents to ensure accuracy and compliance with submission requirements
Required qualifications
- Bachelor's degree with 4+ years of experience in Regulatory Operations
- Experience with Accenture StartingPoint Templates and Veeva RIM preferred
- Demonstrated expertise in Microsoft Word formatting and PDF publishing
- Strong understanding of eCTD submission structure and document standards
- Experience in technical quality control of regulatory submissions
Complete Job Description
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