Regulatory Submission Publishing Specialist

Virtual Company; Branchburg Township (NJ); Remote; USD 38,000 - 51,000; Full time

Job summary

The Fountain Group is hiring a Regulatory Submission Publishing Specialist to publish regulatory dossiers for diagnostic products across US, EU and global markets, working remotely. You will prepare, publish, validate, and electronically submit submissions using publishing platforms and gateways, review validation reports, resolve issues, and ensure compliance and audit readiness.

Must have a Life Sciences bachelor’s, 5+ years in regulatory submission publishing, knowledge of FDA/EMA/ICH, and

Qualifications

• 5+ years of regulatory submission publishing experience in diagnostics or related life sciences.
• Regulatory dossier preparation, publishing, validation, and electronic submission.
• FDA, EMA, and ICH regulatory requirements.
• Diagnostic and life sciences regulatory submissions, including 510(k), PMA, BLA, IND, IDE, and IVDR.
• Regulatory submission quality control (QC), validation report review, and publishing issue resolution.
• Submission lifecycle management, sequence planning, document traceability, and archiving.
• Regulatory document management and submission readiness.

Responsibilities

• Prepare, publish, validate, and submit regulatory dossiers for diagnostic products across US, EU, and global markets.
• Compile and publish submissions using publishing platforms and gateways.
• Review validation reports, resolve publishing errors, ensure quality and compliance.
• Manage submission lifecycle activities, sequence planning, traceability, and archiving.
• Maintain regulatory document repositories and publication databases for audit readiness.
• Implement publishing process improvements, including automation and RPA.
• Support evolving regulatory requirements and reliance pathways.

Skills

Regulatory publishing

FDA EMA ICH

510(k) submissions

PMA BLA IND

DMS CMS

Lifecycle management

Process improvement

Education

Bachelor’s degree in Life Sciences

Advanced degree preferred

Tools

Veeva Vault

Veeva RIM

docuBridge FIVE

eCTD Xpress

Job description

Regulatory Submission Publishing Specialist
Location: Remote
Pay Rate: $27.43–$37.15/hr.
Duration: 1 Year
Job Description

• Prepare, publish, validate, and electronically submit regulatory dossiers for diagnostic products across US, EU, and global markets.

• Compile and publish regulatory submissions using specialized publishing platforms and electronic submission gateways.

• Review submission validation reports, resolve publishing errors, and ensure regulatory submission quality and compliance.

• Manage submission lifecycle activities, sequence planning, document traceability, and regulatory archiving.

• Maintain regulatory document repositories and publication databases to support audit readiness and data integrity.

• Implement publishing process improvements, automation, AI, and robotic process automation (RPA) to improve submission efficiency.

• Support evolving global regulatory requirements and emerging regulatory pathways, including reliance pathways.

Education

• Bachelor’s degree in Life Sciences, Regulatory Science, Quality Assurance, or a related field.

• Advanced degree preferred.

Required Skills

• 5+ years of regulatory submission publishing experience in diagnostics or related life sciences.

• Regulatory dossier preparation, publishing, validation, and electronic submission.

• FDA, EMA, and ICH regulatory requirements.

• Diagnostic and life sciences regulatory submissions, including 510(k), PMA, BLA, IND, IDE, and IVDR.

• Regulatory submission quality control (QC), validation report review, and publishing issue resolution.

• Submission lifecycle management, sequence planning, document traceability, and archiving.

• Regulatory document management and submission readiness.

Preferred Skills

• Veeva Vault, Veeva RIM, LORENZ docuBridge FIVE, or eCTD Xpress.

• FDA ESG, FDA CCP, EMA Common Gateway, and Notified Body submission portals.

• Document Management Systems (DMS) and Content Management Systems (CMS).

• AI, robotic process automation (RPA), and regulatory publishing automation tools.

• Experience with global regulatory requirements beyond the US and EU.

• Continuous process improvement, publishing workflow optimization, and leadership or mentoring experience.