Regulatory Submission Publishing Specialist

DAWAR CONSULTING INC

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

Posted 10/30/2026contractRemote • New Jersey • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory submission publishing for diagnostic products, ensuring compliance with FDA, EMA, and ICH standards while utilizing advanced regulatory publishing tools. Proven ability to manage multiple submission deadlines and optimize processes through automation and continuous improvement.

Highest-signal resume keywords

Regulatory Submission PublishingVeeva VaultFDA Regulatory RequirementsECTD XpressAI and RPA Tools

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory Dossier PreparationSubmission Quality ChecksLifecycle ManagementRegulatory Document ArchivingDiagnostic Product SubmissionsSubmission Process OptimizationValidation Report ReviewPublishing Error ResolutionSubmission Sequence ManagementRegulatory Compliance

Soft Skills

CollaborationCommunicationIndependent ManagementLeadershipMentoring

Tools & Technologies

LORENZ docuBridge FIVEVeeva RIMDMSCMSFDA CCP/ESGNotified Body PortalsEMA Common Gateway

Industry Keywords

Life SciencesRegulatory ScienceQuality Assurance510(k)PMABLAINDIDEIVDRGlobal Regulatory Requirements

Tech Stack

Tools & technologies

RPAVault

About the role

Key responsibilities & impact

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 using 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
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 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

Requirements

What you’ll need

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 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
Ability to manage multiple submission deadlines independently
Advanced degree preferred
Experience with diagnostic product submissions, including 510(k), PMA, IVDR, and related regulatory pathways preferred
Familiarity with global regulatory requirements beyond the US and EU preferred
Experience with AI, RPA, and regulatory publishing automation tools preferred
Background in continuous improvement and submission process optimization preferred
Previous leadership, mentoring, or training experience preferred

Benefits

Comp & perks

Remote work arrangement
Long-term contract opportunity