Regulatory Submission Publishing Specialist

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Prepare, publish, validate, and electronically submit regulatory dossiers for diagnostic products, including 510(k), PMA, BLA, IND, IDE, and IVDR submissions.

• Compile and publish submission packages utilizing Veeva Vault, LORENZ docuBridge FIVE, and eCTD Xpress.

• Oversee electronic submissions via FDA CCP/ESG, Notified Body portals, and the EMA Common Gateway.

• Conduct submission quality checks, review validation reports, and address publishing errors.

• Manage submission sequences, lifecycle activities, timelines, traceability, and archiving of regulatory documents.

• Maintain regulatory document repositories and publishing databases utilizing Veeva Vault, Veeva RIM, DMS, and CMS platforms.

• Collaborate with Regulatory Leads, commercial affiliates, vendors, and IT teams to address publishing challenges and ensure timely submissions.

• Ensure adherence to FDA, EMA, and ICH regulatory standards and the evolving global requirements.

• Communicate submission-readiness criteria and assist regulatory teams with publishing best practices.

• Identify opportunities to enhance submission processes through automation, AI, and robotic process automation (RPA).

• Support the development of emerging global regulatory pathways and requirements, including reliance pathways.

⛳️ Requirements

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

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

• 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 comprehension of FDA, EMA, and ICH regulatory requirements.

• Capability to manage multiple submission deadlines independently.

• Advanced degree is preferred.

• Experience with diagnostic product submissions, including 510(k), PMA, IVDR, and related regulatory pathways is preferred.

• Familiarity with global regulatory requirements beyond the US and EU is preferred.

• Experience with AI, RPA, and regulatory publishing automation tools is preferred.

• Background in continuous improvement and submission process optimization is preferred.

• Previous leadership, mentoring, or training experience is preferred.

🏝️ Benefits

• Remote work arrangement.

• Long-term contract opportunity.