Remote Regulatory Submissions Specialist: Diagnostics

Apollopros; Branchburg Township (NJ); Remote; USD 55,000 - 103,000; Part time

Job summary

Apollopros is seeking a Regulatory Submission Publishing Specialist for a remote, contract role in the United States. You will lead end-to-end publishing, validation, and electronic submissions for diverse regulatory filings, including 510(k), PMA, BLA, and IVDR.

The role requires 5+ years in regulatory publishing, strong FDA/EMA/ICH knowledge, and experience with Veeva Vault and eCTD Xpress. Flexible remote work supports global timelines and cross-functional teams.

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 life sciences.
• Strong knowledge of FDA/EMA/ICH submission requirements and electronic submissions.
• Experience with complex publishing processes and project coordination.

Responsibilities

• Lead end-to-end preparation, publishing, validation, and electronic submission of regulatory dossiers.
• Support submissions including 510(k), PMA, BLA, IND/IDE, IVDR, and global diagnostics filings.
• Publish using Veeva Vault, LORENZ docuBridge FIVE, and eCTD Xpress; manage gateways.
• Coordinate with regulatory teams and external partners to ensure on-time submissions.
• Quality checks, lifecycle planning, traceability, and archival of regulatory documents.

Skills

Regulatory publishing

FDA/EMA knowledge

Project management

Cross-functional collaboration

GxP/quality compliance

Education

Bachelor's in Life Sciences or Regulatory Science

Advanced degree preferred

Tools

Veeva Vault

LORENZ docuBridge FIVE

eCTD Xpress

DMS/CMS regulatory repositories

Job description

Apollopros is seeking a Regulatory Submission Publishing Specialist for a remote, contract role in the United States. You will lead end-to-end publishing, validation, and electronic submissions for diverse regulatory filings, including 510(k), PMA, BLA, and IVDR.

The role requires 5+ years in regulatory publishing, strong FDA/EMA/ICH knowledge, and experience with Veeva Vault and eCTD Xpress. Flexible remote work supports global timelines and cross-functional teams.