Regulatory Submission Publishing Specialist

This is a remote position.

Job Description

We are seeking an experienced Regulatory Submission Publishing Specialist to join our Diagnostics Regulatory Affairs team. This role will manage the preparation, publishing, quality control, and electronic submission of regulatory dossiers supporting global diagnostic product registrations, primarily across the US and EU markets.

The ideal candidate will have hands-on experience with regulatory publishing tools, electronic submission gateways, and global regulatory requirements, along with a strong understanding of diagnostics regulatory submissions.

Key Responsibilities

• Lead preparation, publishing, validation, and electronic submission of regulatory dossiers for diagnostic products, including 510(k), PMA, BLA, IND, IDE, and IVDR submissions.
  

• 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 to ensure accuracy and compliance.
  

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

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

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

• Ensure compliance with applicable FDA, EMA, and ICH regulatory standards and evolving global requirements.
  

• Communicate submission-readiness requirements and support regulatory teams with publishing best practices.
  

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

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

Required Qualifications

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

• 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 the ability to manage multiple submission deadlines independently.
  

Preferred Qualifications

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

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

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

• Background in continuous improvement and submission process optimization.
  

• Previous leadership, mentoring, or training experience.