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Ectd Publishing Jobs (NOW HIRING)

SK Life Science

Manager, Regulatory Operations

Paramus, NJ · On-site

$115K - $140K/yr

Minimum of 4-6 years of eCTD publishing experience in pharmaceutical industry. * Knowledge of health authority procedures/guidance regarding electronic submissions. * Knowledge of industry trends ...

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How much do ectd publishing jobs pay per hour?

As of Jul 13, 2026, the average hourly pay for ectd publishing in the United States is $23.33, according to ZipRecruiter salary data. Most workers in this role earn between $20.19 and $26.20 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as an eCTD Publisher, and why are they important?

To thrive as an eCTD Publisher, you need a solid understanding of regulatory submission requirements, document management, and familiarity with pharmaceutical or biotechnology industry standards, often supported by a relevant degree. Proficiency in eCTD publishing software (such as Lorenz DocuBridge, Extedo eCTDmanager, or GlobalSubmit), as well as knowledge of FDA and EMA submission portals, is typically required. Strong attention to detail, organizational skills, and effective communication are crucial soft skills that help ensure accuracy and compliance. These skills and qualifications are vital for producing error-free regulatory submissions and meeting strict deadlines in a highly regulated environment.

What is eCTD publishing?

eCTD publishing refers to the process of preparing and compiling regulatory submission documents in the Electronic Common Technical Document (eCTD) format, which is required by health authorities like the FDA and EMA. This process involves organizing, formatting, hyperlinking, bookmarking, and validating documents to meet strict technical standards for electronic submissions. eCTD publishers use specialized software to ensure that all documents are compliant, navigable, and accepted by regulatory agencies. The goal is to facilitate the review and approval of pharmaceuticals and biologics by providing a standardized electronic format for submissions.

What are some common challenges faced by professionals in eCTD Publishing, and how can they be addressed?

Professionals in eCTD Publishing often encounter challenges such as managing complex regulatory requirements, handling version control for submission documents, and meeting tight deadlines for regulatory filings. Staying organized and up-to-date with the latest regional guidelines is essential, as regulatory agencies frequently update their submission standards. Utilizing robust publishing software and maintaining clear communication with cross-functional teams—including regulatory affairs, medical writers, and quality assurance—can help streamline the process and minimize errors. Regular training and process reviews also support consistent, high-quality submissions.

What is the difference between Ectd Publishing vs Ectd Coordinator?

AspectEctd PublishingEctd Coordinator
Primary RolePreparing, formatting, and publishing electronic submissions (eCTD) for regulatory agenciesManaging and coordinating the eCTD submission process, ensuring compliance and timelines
Required SkillsTechnical knowledge of eCTD standards, document formatting, and publishing toolsProject management, communication, and regulatory knowledge
Work EnvironmentTypically involves working with document management systems and publishing softwareCollaborative environment coordinating between teams and regulatory bodies

While Ectd Publishing focuses on the technical creation and formatting of electronic submissions, Ectd Coordinator manages the overall submission process, ensuring compliance and timely delivery. Both roles require knowledge of eCTD standards but differ in scope and responsibilities.

More about Ectd Publishing jobs
What cities are hiring for Ectd Publishing jobs? Cities with the most Ectd Publishing job openings:
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Ectd Publishing jobs near you
Infographic showing various Ectd Publishing job openings in the United States as of July 2026, with employment types broken down into 82% Full Time, and 18% Contract. Highlights an 82% In-person, and 18% Remote job distribution, with an average salary of $48,522 per year, or $23.3 per hour.
Regulatory Publishing consultance

Regulatory Publishing consultance

Arete Technologies, Inc.

Princeton, NJ

Contractor

Re-posted 4 days ago

Job description

Company Description

Arete Technologies, Inc. offers set of innovative Consulting and Outsourcing services, bridging the gap between requirements and outputs of various dexterous and facile companies worldwide. The thrust of providing global deliverables with focus on providing paramount and unsurpassed services combined with cost saving solutions to the clients

We understand the business requirements in the present day corporate scenario and aspire to provide world-class services enabling the organization to burgeon and flourish while keeping the work-life balance intact. The Global delivery mechanism followed at Arete Technologies, Inc. saddles proficient schemas and unconventional channels to provide one-stop solutions for all your workforce needs.

our Team is an exquisite amalgamation of vast experiences of over 30 years in IT Consulting and Staffing industry. Connoisseurs in the field of staff augmentation for IT, we operate on 24 by 7 model with an aim of providing affordable and adept professionals with an assurance of satisfaction for both Consultants and Clients.

We are pre-eminent service providers in the field of staff augmentation, IT Consultancy, Software development, Web Development providing unexcelled services and focusing on both the employers and employees.

Job Description

Technical/Functional knowledge on Content Management Systems (Documentum, Webtop, FirstDoc, CARA etc) and eCTD Publishing Tools (Insight Publisher, eCTDXpress etc)

5+ yrs of IT experience and 4+ relevant years of experience in Regulatory publishing technologies

Strong knowledge in Publishing technologies and Labelling systems (ALiCE)

Comfortable working in Java, PL/SQL, DQL, APIs

Have working experience on upgrade projects and assessing the system in integrating with other applications

Participates in Change Management, Disaster Recovery and Production Support operations

Worked on Change Control Procedure

Additional Information

Best Regards

Alka Bhatia

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