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ProKidney

Regulatory Publishing Consultant

Position SummaryProKidney is seeking a Regulatory Publishing Consultant to support the preparation, QC, and publishing of submission-ready regulatory documents and dossiers. This consultant will work ...

Taiho Oncology

$86K - $102K/yr

Under the direction of regulatory affairs operations management, the incumbent with minimal assistance conducts and supports global regulatory affairs dossier publishing activities. The activities ...

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How much do regulatory publisher jobs pay per hour?

As of Jul 29, 2026, the average hourly pay for regulatory publisher in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

What are some typical challenges a Regulatory Publisher might face in their daily work?

Regulatory Publishers often encounter tight deadlines and frequently changing regulatory requirements, which can make prioritizing tasks and staying up-to-date a challenge. Managing complex submissions that involve compiling, formatting, and validating large volumes of documentation requires both technical and organizational expertise. Additionally, close collaboration with regulatory affairs, medical writers, and quality assurance teams is essential to ensure submissions are accurate and compliant. Overcoming these challenges involves a keen attention to detail, adaptability, and strong communication skills, all of which are highly valued in this role.

What does a Regulatory Publisher do?

A Regulatory Publisher is responsible for compiling, formatting, and submitting regulatory documents to health authorities, ensuring compliance with global submission standards such as eCTD (Electronic Common Technical Document). They work closely with regulatory affairs teams to prepare dossiers for drug approvals, variations, and renewals. Their role involves quality control, document troubleshooting, and staying up to date with regulatory submission requirements. Effective use of publishing software and strict adherence to guidelines are essential for ensuring successful submissions.

What are the key skills and qualifications needed to thrive in the Regulatory Publisher position, and why are they important?

To thrive as a Regulatory Publisher, you need a thorough understanding of regulatory submission requirements, document management, and attention to detail, typically supported by experience in the pharmaceutical or biotechnology industries. Proficiency with electronic submission tools such as eCTD publishing software (e.g., Lorenz DocuBridge, Extedo), and familiarity with FDA or EMA guidelines, are highly valued. Strong organization, effective communication, and the ability to manage multiple projects simultaneously are important soft skills. These abilities are vital for ensuring timely, compliant submissions and efficient collaboration across regulatory and project teams.

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Regulatory Publisher jobs near you
Infographic showing various Regulatory Publisher job openings in the United States as of July 2026, with employment types broken down into 3% Locum Tenens, 85% Full Time, 8% Part Time, 1% Temporary, and 3% Contract. Highlights an 88% Physical, 4% Hybrid, and 8% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Regulatory Publishing Manager (Contract)

Vertex Pharmaceuticals Incorporated

Remote

$65/hr

Full-time

Posted 19 days ago

Vertex Pharmaceuticals rating

6.5

Company rating: 6.5 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

78th of 86 rated pharmaceutical

Job description


The Regulatory Publishing Manager supports document-level regulatory publishing activities within a global Veeva Vault Publishing environment. This role focuses on preparing submission-ready regulatory documents through advanced Microsoft Word formatting, dynamic linking within Veeva, and compliant PDF generation. This position works within submission documents to ensure technical accuracy, formatting quality, and alignment with global regulatory standards. The role partners closely with document authors and regulatory stakeholders to embed quality into source documents, reduce time-to-file, and improve document reusability. This is an evolving environment requiring a self-starter comfortable working with refining templates, checklists, and processes.
Key Duties and Responsibilities
  • Format complex regulatory documents in Microsoft Word to meet submission-ready standards.
  • Apply structured formatting, hyperlinks, bookmarks, cross-references, and linking best practices.
  • Convert Word source files into compliant, high-quality PDFs.
  • Work within Veeva Vault Publishing to manage document workflows and dynamic linking functionality.
  • Support report-level publishing (e.g., clinical reports, protocols, periodic reports).
  • Ensure alignment with global regulatory publishing standards and eCTD requirements.
  • Partner with document authors and SMEs to build quality into Word source documents early.
  • Provide guidance on submission-ready formatting standards.
  • Support refinement of evolving submission checklists and templates.
  • Manage multiple concurrent document priorities independently.

Knowledge and Skills
  • 5-7 years of global regulatory publishing experience.
  • Strong knowledge of eCTD structure and electronic submission requirements.
  • Experience with Veeva Vault Publishing (direct experience strongly preferred).
  • Advanced Microsoft Word formatting expertise.
  • Experience generating submission-ready PDFs.
  • Ability to work independently in a developing, non-cookie-cutter environment.
  • Strong attention to detail and quality mindset.
  • Effective cross-functional communication skills.

Education and Experience
  • Bachelor's degree preferred but not required.
  • Experience supporting global regulatory submissions required.
  • Experience working in a system transition or evolving publishing environment preferred.

Contract Length: 12 months, with the chance to extend
Pay Range
$65/hr. - $75/hr.
Shift/Hours
Monday - Friday. Remote. EST hours.
Requisition Disclaimer
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals ("Vertex"). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex's Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners
(collectively, "Atrium Alerts"). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at privacyadministrator@atriumstaff.com.
If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email.
No C2C or Third-Party Vendors

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