Regulatory Submission Publishing Specialist

Job not on LinkedIn

🔥 13 hours ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 25%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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DAWAR CONSULTING INC

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2009

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

DAWAR CONSULTING INC. is a trusted provider of workforce solutions and professional services tailored for the Medical Science industry. Specializing in Human Capital Management (HCM) and ITSM consulting, DAWAR offers expert implementation of SaaS and Cloud-based solutions from platforms like Workday and ServiceNow. Their comprehensive staffing services include global talent acquisition, recruitment process outsourcing, and staff augmentation, ensuring that they connect skilled professionals with career opportunities while enhancing organizational productivity and efficiency.

📋 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 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

• 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

• Remote work arrangement • Long-term contract opportunity

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