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Regulatory Publisher Jobs (NOW HIRING)

Sapta Global Inc

Regulatory Analyst

Signal Hill, CA

Regulatory Submissions Management and Operations for Janssen R&D Project Goal (Mandatory): The ... Maintain open, timely and effective communications with all publishing contributors and responsible ...

JobRx, Inc.

Director, Regulatory Affairs

Durham, NC · On-site

$130 - $160/hr

They will facilitate publishing activities with internal and external stakeholders including authoring cover letters forms, eCTD sections and preparing documents for submission to regulatory agencies ...

Pelthos Therapeutics

Director, Regulatory Affairs

Durham, NC · On-site

$135K - $179K/yr

They will facilitate publishing activities with internal and external stakeholders including authoring cover letters forms, eCTD sections and preparing documents for submission to regulatory agencies ...

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How much do regulatory publisher jobs pay per hour?

As of Aug 20, 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 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 as a regulatory publisher?

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.

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.

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Regulatory Publisher jobs near you
Infographic showing various Regulatory Publisher job openings in the United States as of August 2026, with employment types broken down into 2% As Needed, 86% Full Time, 9% Part Time, and 3% Contract. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Regulatory Affairs Specialist

Artech Information System LLC

Cambridge, MA

Contractor

Re-posted 3 days ago

Job description

Company Description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

The Regulatory Affairs Operations (RA Ops) submission group is organized to provide submission development support to project teams and the regulatory community. The focus of this position will be to publish, submit and maintain regulatory filings in coordination with Global Regulatory Leads. The role works to tight, business-critical deadlines within a highly regulated environment. 

She/he also ensures that compliance standards are met for receipt and delivery of information to and from external consultants and health authorities.

Expert in publishing capabilities of all modules with a competency in the component locations within the eCTD backbone structure.

Support Global Regulatory Leads in the planning, development, and publishing of submissions.

Control submission component receipt and workflow completion to ensure a high quality final submission. Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted.

Coordinate publishing tasks associated with assigned submissions, including peer review of submissions generated by other publishers.

Ability to contribute to brainstorming and troubleshooting of technical issues that impact validation requirements for submission dispatch.

Dispatch submissions through the FDA Gateway

Ensure adherence to internal and external standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the lifecycle of the application.

Archive submissions both electronic and paper.

Skills: 

Proficient in use of MS Office, Adobe Professional, Adobe Add-ins, Publishing Software (sCubed and/or eCTD Manager), Validation Tools and Document Management Systems.

Demonstrate ability to function autonomously in a matrix environment.

Knowledgeable in appropriate ICH and FDA regulations pertaining to regulatory and technical requirements for electronic submissions.

Must be detail oriented and articulate with strong analytical, decision-making, and interpersonal 

Demonstrate regulatory knowledge and awareness, technical competence, sound judgment, and a professional demeanor.

Demonstrate flexibility in dealing with change and diversity.

Ability to multi-task in a fast paced environment.

All candidates should have an understanding of the concepts around regulatory affairs and significant knowledge of submissions processes.

Proficient in formatting Word documents prior to publishing and electronic navigation for Adobe documents.

Education:

At least a bachelor s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience. Four years submission publishing experience.


Additional Information

Best Regards,

Anuj Mehta

973-967-3402


Artech logo

About Artech

Sourced by ZipRecruiter

Artech is a leading IT staffing and consulting company based in Morristown, NJ, US. Since its foundation in 1992, Artech has mastered in complementing human expertise with technology and business acumen to produce world-class staffing solutions. The company caters to diverse industry sectors, including financial services, healthcare, telecommunication, energy and utilities, supply chain, and retail. It provides IT consulting, project management, professional and staff augmentation, and managed staffing services. Artech's mission is to provide exceptional IT staffing services to its clients by comprehending their business needs and then crafting a customized staffing strategy. Its notable achievement includes being recognized as one of the largest IT staffing companies in the U.S, according to Staffing Industry Analysts (SIA).

Industry

Recruiting and staffing services

Company size

10,000+ Employees

Headquarters location

Morristown, NJ, US

Year founded

1992

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