Remote Regulatory Submissions Publisher for Diagnostics

Spectraforce Technologies, Inc.; Branchburg Township (NJ); Remote; USD 90,000 - 130,000; Full time

Job summary

Spectraforce Technologies, Inc. is seeking a Regulatory Submission Publishing Specialist to join the Diagnostics Regulatory Affairs team.

This role focuses on end-to-end preparation, publishing, and electronic submission of regulatory documents for a global diagnostics portfolio, with emphasis on US and EU markets. You will use platforms such as Veeva Vault, LORENZ docuBridge FIVE, and eCTD Xpress, manage gateways (FDA CCP/ESG, EMA Common Gateway), perform quality checks, and ensure timely,

Qualifications

• Bachelor's degree in Life Sciences, Regulatory Science, 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.
• Excellent organizational and communication skills.
• Experience in continuous improvement and automation.
• Leadership or mentoring experience is a plus.

Responsibilities

• 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 (FDA CCP/ESG, Notified Body portals, EMA Gateway).
• Conduct quality control and compliance checks on submissions to prevent errors.
• Oversee submission lifecycle management and sequence planning.
• Collaborate with Regulatory Leads, affiliates, vendors, and IT to troubleshoot publishing challenges.
• Maintain regulatory document repositories in Veeva Vault, Veeva RIM, DMS, and CMS.
• Apply FDA, EMA, ICH standards during publishing and submission lifecycle.
• Communicate requirements for 'submission ready' publishing and contribute to process improvements.
• Drive adoption of AI and RPA to enhance publishing efficiency.
• Support emerging global regulatory requirements and pathways, including reliance.

Skills

AI

RPA

Automation

FDA standards

EMA standards

ICH guidelines

Leadership

Communication

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Tools

Veeva Vault

LORENZ docuBridge FIVE

eCTD Xpress

Job description

Spectraforce Technologies, Inc. is seeking a Regulatory Submission Publishing Specialist to join the Diagnostics Regulatory Affairs team.

This role focuses on end-to-end preparation, publishing, and electronic submission of regulatory documents for a global diagnostics portfolio, with emphasis on US and EU markets. You will use platforms such as Veeva Vault, LORENZ docuBridge FIVE, and eCTD Xpress, manage gateways (FDA CCP/ESG, EMA Common Gateway), perform quality checks, and ensure timely,