Remote Regulatory Publishing Specialist – Diagnostics

BEPC Inc. - Business Excellence Professional Consulting; Branchburg Township (NJ); Remote; USD 49,000 - 53,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Job summary

BEPC Inc. seeks a Regulatory Publishing Specialist for a fully remote, W2 contract role (12 months, extensions possible). The candidate will manage regulatory dossiers for diagnostic products, support 510(k)/PMA/BLA/IND/IDE/IVDR/eCTD submissions, and coordinate with FDA/EMA portals.

Proficiency with Veeva Vault, LORENZ docuBridge, or eCTD Xpress is essential. The ideal candidate has 5+ years in regulatory publishing, strong FDA/EMA knowledge, and collaborative skills across cross-functional

Qualifications

• Minimum 5 years of regulatory submission publishing experience.
• Strong understanding of FDA, EMA, and ICH regulatory standards.
• Experience with electronic regulatory submissions and publishing platforms.

Responsibilities

• Prepare, compile, publish, and submit electronic regulatory dossiers for diagnostic products.
• Support regulatory submission types (510(k), PMA, BLA, IND, IDE, IVDR, eCTD).
• Use publishing platforms such as Veeva Vault, LORENZ docuBridge FIVE, and eCTD Xpress.
• Manage submissions through FDA CCP, FDA ESG, EMA gateways, and Notified Body portals.
• Perform submission validation, QC, and compliance checks.
• Review validation reports and troubleshoot publishing errors.
• Coordinate submission lifecycle, sequencing, and timelines.
• Maintain regulatory documentation repositories (Veeva RIM/DMS/CMS).
• Ensure compliance with FDA/EMA/ICH and global requirements.
• Collaborate with Regulatory Affairs, IT, and external vendors.
• Maintain submission traceability and audit-ready records.
• Identify opportunities for process improvement and automation.

Skills

Regulatory knowledge

Attention to detail

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Life Sciences/Regulatory Science

Advanced degree preferred

Tools

Veeva Vault

LORENZ docuBridge FIVE

eCTD Xpress

FDA CCP

FDA ESG

EMA portals

DMS/CMS

Job description

BEPC Inc. seeks a Regulatory Publishing Specialist for a fully remote, W2 contract role (12 months, extensions possible). The candidate will manage regulatory dossiers for diagnostic products, support 510(k)/PMA/BLA/IND/IDE/IVDR/eCTD submissions, and coordinate with FDA/EMA portals.

Proficiency with Veeva Vault, LORENZ docuBridge, or eCTD Xpress is essential. The ideal candidate has 5+ years in regulatory publishing, strong FDA/EMA knowledge, and collaborative skills across cross-functional