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Ectd Publisher 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 publisher jobs pay per hour?

As of Jul 14, 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 in the Ectd Publisher position, and why are they important?

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 job?

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 a typical day look like for an eCTD Publisher working in a regulatory affairs team?

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
Regulatory Publishing consultance

Regulatory Publishing consultance

Arete Technologies, Inc.

Princeton, NJ

Contractor

Re-posted 5 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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