Remote Diagnostics Regulatory Submissions Expert

Dawar Consulting, Inc.; Branchburg Township (NJ); Remote; USD 90,000 - 120,000; Part time

Job summary

Dawar Consulting, Inc. seeks a Regulatory Submission Publishing Specialist to manage the preparation, publishing, and electronic submission of regulatory dossiers for diagnostic products on a contract basis. remote work is available, with focus on US and EU submissions.

You will oversee publishing workflows, quality checks, and cross-functional collaboration with Regulatory Leads, commercial teams, and IT to ensure on-time submissions and compliance with FDA, EMA, and ICH standards.

Qualifications

• Bachelor’s degree in Life Sciences, Regulatory Science, Quality Assurance, or related field.
• 5+ years of experience in regulatory submission publishing within diagnostics or related life sciences industries.
• Hands-on experience with regulatory publishing tools such as Veeva Vault, LORENZ docuBridge FIVE, or eCTD Xpress.
• Experience managing electronic regulatory submissions through FDA, EMA, and Notified Body gateways.
• Strong understanding of FDA, EMA, and ICH regulatory requirements.
• Excellent organizational, communication, and problem-solving skills, with ability to manage multiple submission deadlines independently.

Responsibilities

• Lead preparation, publishing, validation, and electronic submission of regulatory dossiers for diagnostic products.
• Compile and publish submission packages using tools such as Veeva Vault, LORENZ docuBridge FIVE, and eCTD Xpress.
• Manage electronic submissions through FDA CCP/ESG, Notified Body portals, and EMA Common Gateway.
• Perform submission quality checks, review validation reports, and resolve publishing errors.
• Maintain submission sequences, timelines, traceability, and regulatory document archiving.
• Collaborate with Regulatory Leads, affiliates, vendors, and IT teams to resolve publishing challenges.

Skills

Regulatory publishing

Project management

Communication

Education

Bachelor’s degree in Life Sciences/Regulatory Science/Quality Assurance

Advanced degree preferred

Tools

Veeva Vault

LORENZ docuBridge FIVE

eCTD Xpress

Job description

Dawar Consulting, Inc. seeks a Regulatory Submission Publishing Specialist to manage the preparation, publishing, and electronic submission of regulatory dossiers for diagnostic products on a contract basis. remote work is available, with focus on US and EU submissions.

You will oversee publishing workflows, quality checks, and cross-functional collaboration with Regulatory Leads, commercial teams, and IT to ensure on-time submissions and compliance with FDA, EMA, and ICH standards.