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Remote Regulatory Submission Publisher Jobs (NOW HIRING)

Product Life Group

Publishing Officer/ Specialist

Publishing Officer/Specialist The Publishing Officer/Specialist will support regulatory submission publishing activities for global markets as part of the Publishing project. The role focuses on the ...

Codera

Director, Regulatory Affairs

San Diego, CA · Remote

Collaborate with vendors who support regulatory operations-related tasks * Assist with developing and maintaining regulatory document processing and regulatory submission publishing standards and ...

ProKidney

Regulatory Publishing Consultant

PerfectIt, ISI Toolbox, ESG (Electronic Submissions Gateway), Adobe Acrobat Pro, Microsoft Word ... Ability to work independently in a remote environment with clear, proactive communication.Preferred ...

Altimmune

Director, US Regulatory Affairs

Morristown, NJ · On-site +1

$154K - $204K/yr

Depending upon location, this role will be hybrid or remote and will require some travel as ... Manages the preparation and submission of formal regulatory meeting requests and briefing packages ...

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Remote Regulatory Submission Publisher information

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How much do remote regulatory submission publisher jobs pay per hour?

As of Aug 5, 2026, the average hourly pay for remote regulatory submission publisher in the United States is $56.97, according to ZipRecruiter salary data. Most workers in this role earn between $42.07 and $66.59 per hour, depending on experience, location, and employer.

What is a remote regulatory submission publisher?

A Remote Regulatory Submission Publisher is a professional who prepares, formats, and submits regulatory documents to health authorities, such as the FDA or EMA, from a remote location. Their primary responsibility is to ensure that all regulatory submissions comply with current guidelines and technical requirements. They use specialized software to compile, validate, and publish documents, often as part of the drug development process in the pharmaceutical or biotech industries. Working remotely allows them to perform these tasks from anywhere, collaborating virtually with regulatory and project teams.

What are some typical challenges faced by remote regulatory submission publishers, and how can they be effectively managed?

Remote Regulatory Submission Publishers often encounter challenges such as coordinating across multiple time zones, ensuring timely document collection from diverse teams, and maintaining compliance with varying global regulatory requirements. Effective management involves establishing clear communication channels, using collaborative document management systems, and staying updated on submission guidelines for different regions. Proactive organization and regular check-ins with cross-functional teams can help overcome these challenges, ensuring high-quality and compliant submissions.

What is the difference between Remote Regulatory Submission Publisher vs Remote Regulatory Affairs Associate?

AspectRemote Regulatory Submission PublisherRemote Regulatory Affairs Associate
CredentialsTypically requires a degree in life sciences or related field, with experience in document managementRequires a degree in life sciences, with knowledge of regulatory processes and possibly certification in regulatory affairs
Work EnvironmentPrimarily focused on preparing, formatting, and submitting regulatory documentsInvolves broader regulatory strategy, communication with authorities, and compliance oversight
Industry UsageCommonly employed in pharmaceutical, biotech, and medical device industries for submission tasksUsed across similar industries, with additional responsibilities in regulatory planning and strategy

The Remote Regulatory Submission Publisher mainly handles the preparation and submission of regulatory documents, focusing on formatting and compliance. In contrast, the Remote Regulatory Affairs Associate has a broader role, including regulatory strategy, communication, and compliance oversight. Both roles require relevant life sciences credentials but differ in scope and responsibilities.

What are the key skills and qualifications needed to thrive as a remote regulatory submission publisher?

To thrive as a Remote Regulatory Submission Publisher, you need expertise in regulatory submission processes, document management, and a background in life sciences or a related field. Familiarity with eCTD publishing tools (like Lorenz or Veeva Vault), regulatory databases, and understanding of global submission requirements is typically expected. Attention to detail, strong organizational skills, and effective remote communication are crucial soft skills for coordinating with cross-functional teams. These competencies ensure accurate, compliant, and timely submissions to regulatory authorities, which is critical for product approvals and company success.
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Remote Regulatory Submission Publisher jobs near you
Infographic showing various Remote Regulatory Submission Publisher job openings in the United States as of July 2026, with employment types broken down into 87% Full Time, 5% Part Time, and 8% Contract. Highlights an 100% Remote job distribution, with an average salary of $118,493 per year, or $57 per hour.

Remote Regulatory Affairs contractor

Globalchannelmanagement

Atlanta, GA • Remote

$99 - $100/hr

Full-time

Re-posted 9 days ago

Job description

Remote Regulatory Affairs contractor requires:

  • Bachelor's degree in engineering, life sciences, regulatory affairs, legal or a related field
  • 5-10 years+ of global medical device regulatory experience
  • Proven experience preparing, writing and submitting FDA 510k submissions (end to end)
  • Experience with ophthalmic devices, capital equipment, diagnostic devices, software in medical devices, cybersecurity
  • Strong working knowledge of:
    • FDA regulations (21 Parts 807, 820)
    • FDA guidance documents and eStar requirements
    • Experience with Canadian regulations, EU MDR (2017/745) including Class lla, Tech docs Annex ll/lll
  • Demonstrated ability to work independently as a contractor in a fast-paced environment
  • Experience filing medical device submissions in China and other countries
  • Experience with audiology devices
  • Experience with artificial-intelligence enabled devices
  • Strong technical writing and documentation skills
  • Ability to translate complex technical information into regulatory submissions
  • Detail-oriented with strong organization skills
  • Effective communicator across technical and non-technical stakeholders
  • Ability to manage multiple deliverables and timelines

DUTIES:

  • FDA 510(k) submission
  • Conduct comprehensive review of technical documentation (design controls, V&V, risk, labeling, clinical evidence, and software as applicable) to ensure completeness, quality, and regulatory compliance
  • Perform detailed regulatory gap assessments against FDA requirements (21 CFR Parts 807, 820, and applicable FDA guidance documents)
  • Author, compile and deliver a complete 510k submission, including preparation in FDA eSTAR format,
  • Lead submission lifecycle activities, including:
    • Acceptance Review support (RTA readiness)
    • Substantive Review coordination
    • Drafting and submission of responses to FDA requests for Additional Information, Interactive review communications
    • Updating submission content and modules as required
  • Interface cross-functionally to incorporate Business inputs and ensure alignment throughout the review process.
  • Provide regulatory leadership through FDA clearance.
  • EU MDR Technical Documentation Support
  • Conduct EU MDR readiness assessment aligned with Notified Body expectations and conformity assessment requirements.
  • Perform critical review and gap analysis of EU MDR technical file
  • Provide targeted recommendations to ensure audit-readiness and Notified Body acceptance
  • Lead or support submission to obtain CE Mark
  • Health Canada submission
  • Global Regulatory Strategy and Advisory