Global Regulatory Submissions Lead

Sharp Decisions; United States; Vor Ort; USD 42.000 - 60.000; Vollzeit

Zusammenfassung

Sharp Decisions is seeking a Regulatory Submission Publishing Specialist to join our Diagnostics Regulatory Affairs team in the United States. This role leads end-to-end preparation, publishing, and electronic submission of regulatory documents across FDA, EMA, and ICH standards.

You will work with platforms like Veeva Vault and eCTD Xpress, manage gateways, ensure audit-ready documentation, and drive process improvements including automation and AI adoption.

Qualifikationen

• Bachelor’s degree in Life Sciences, Regulatory Science, Quality Assurance, or related field.
• 5+ years’ experience in regulatory submission publishing for diagnostics or related life science areas.
• Experience with AI, RPA, or publishing automation tools is highly preferred.
• Strong understanding of FDA, EMA, ICH regulatory standards and global regulatory environments.

Aufgaben

• Lead the preparation, publishing, and electronic submission of regulatory dossiers for diagnostics products.
• Use platforms like Veeva Vault, LORENZ docuBridge FIVE, or eCTD Xpress for compiling, validating, and publishing submission packages.
• Manage submissions through electronic submission gateways including FDA CCP/ESG, Notified Body portals, and EMA gateway.
• Conduct QC and compliance checks on submissions and perform submission quality assurance.
• Oversee submission lifecycle management and sequence planning to align with global timelines.

Kenntnisse

Regulatory publishing

Attention to detail

Multitasking

Communication

Ausbildung

Bachelor’s degree in Life Sciences/Regulatory Science/QA

Tools

AI

RPA

Automation tools

Jobbeschreibung

Sharp Decisions is seeking a Regulatory Submission Publishing Specialist to join our Diagnostics Regulatory Affairs team in the United States. This role leads end-to-end preparation, publishing, and electronic submission of regulatory documents across FDA, EMA, and ICH standards.

You will work with platforms like Veeva Vault and eCTD Xpress, manage gateways, ensure audit-ready documentation, and drive process improvements including automation and AI adoption.