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Slipstream IT

PA

Configure RIM Publishing: rendition profiles, binder/output templates, and publishing configuration supporting eCTD and NeeS output. Release & Environment Management * Manage sandbox refreshes ...

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How much do ectd publisher jobs pay per hour?

As of Aug 9, 2026, the average hourly pay for ectd publisher in the United States is $29.90, according to ZipRecruiter salary data. Most workers in this role earn between $23.08 and $34.38 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as an eCTD publisher?

To thrive as an eCTD Publisher, you need a strong understanding of regulatory submission standards, document management, and attention to detail, often supported by a degree in life sciences or a related field. Familiarity with eCTD publishing software (such as Lorenz DocuBridge, Extedo, or InSight Publisher), as well as knowledge of FDA and EMA regulatory submission requirements, is typically required. Excellent organizational skills, communication, and the ability to problem-solve under deadlines are important soft skills for this role. These skills ensure accurate, compliant, and timely electronic regulatory submissions essential for pharmaceutical product approvals.

What is an eCTD publisher?

An eCTD Publisher is responsible for preparing, formatting, and submitting electronic Common Technical Document (eCTD) submissions to regulatory agencies such as the FDA or EMA. They ensure that all documents meet regulatory requirements, follow specific guidelines, and are error-free for seamless acceptance. This role involves using specialized publishing software, managing submission timelines, and collaborating with regulatory teams to compile accurate and complete applications.

What does an eCTD publisher do?

A typical day for an eCTD Publisher involves preparing, compiling, and validating electronic regulatory submissions to health authorities, ensuring that all documents meet technical and formatting standards. You’ll collaborate closely with cross-functional teams in regulatory affairs, quality assurance, and clinical research to gather required documentation and resolve any content or formatting issues. Attention to deadlines is crucial, as submissions often have tight regulatory timelines. You may also participate in system testing, implement process improvements, and stay updated on changing agency guidelines to ensure ongoing compliance.

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Ectd Publisher jobs near you
Infographic showing various Ectd Publisher job openings in the United States as of August 2026, with employment types broken down into 83% Full Time, 9% Part Time, 1% Temporary, and 7% Contract. Highlights an 86% Physical, 3% Hybrid, and 11% Remote job distribution, with an average salary of $62,196 per year, or $29.9 per hour.

Sr. Regulatory Affairs Associate

Avion Pharmaceuticals

Alpharetta, GA • Remote

Full-time

Posted 2 days ago

New

Job description

Summary/Objective

The Senior Regulatory Affairs Associate is responsible for preparing submissions in eCTD format, actively participating in client meetings, interacting with the various governmental agencies when needed, and assessing change control for regulatory impact. In addition, the Associate will aid in the development and training of other associates in creating compliant submissions and understanding the impact of regulation changes.

Essential Functions

  • Independently gather documentation, draft, and prepare eCTD-compliant submissions (applications, supplements, and annual reports) based on client needs.
  • Review the work of other Regulatory staff for content, format, and validation.
  • Proactively work with other departments to provide information and suitable documentation for clients to meet submission deadlines.
  • Proactively work with clients to ensure a successful working relationship by providing information, documentation, and regulatory advice in a timely manner.
  • Revise labeling as requested by the FDA, internal and external partners, or to conform to changes to the RLD.
  • Edit, validate, and eList a drug product SPL as needed.
  • Participate in audits by federal, state, and local Agencies as needed.
  • Actively train on new regulations and in governmental agency webinars to increase regulatory knowledge and readiness
  • Review federal, state, and local regulatory guidance and revisions to ensure continuing compliance.
  • Represent the department at interdepartmental meetings and governmental agency meetings.
  • Participate in compliance activities as required.

Required Education and Experience

  • Bachelor’s degree in chemistry or life sciences, or 5-7 years of applicable experience.
  • Working understanding of basic office applications (Word, Excel, Acrobat).
  • Preparation and maintenance of eCTD submissions and lifecycle.

preferred education and experience

  • Working knowledge of CDERDirect, Electronic Submissions Gateway, and SPL Xforms.
  • Familiarity with eCTD publishing and electronic document management systems
  • RAC certification a plus, but not mandatory.

Position Type/Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 4:30 p.m. Occasional evening and weekend work may be required as job duties demand.

Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected.

Physical Demands

The employee is required to sit at a computer for long periods of time. Occasional walking or driving between facilities is needed. This job occasionally requires the need to be able to lift up to ten (10) pounds.

Work Environment

This job operates in a professional office environment and business casual attire. This role may be remote at the discretion of the manager based on current business needs. Occasionally, required in-office work will be needed for remote specialists to meet department needs. This role routinely uses standard office equipment such as computers, phones, photocopiers, and scanners.

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