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ProKidney

Regulatory Publishing Consultant

Preferred QualificationsExperience supporting eCTD and/or non-eCTD publishing workflows (region-specific experience a plus).Familiarity with common regulatory document standards and expectations (e.g ...

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 ...

Taiho Oncology

$86K - $102K/yr

Advanced skills in eCTD publishing tools (including docuBridge), MS-Office, Adobe Acrobat applications, electronic document management systems (preferably Generis' CARA), and the ability to learn ...

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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.

Senior Associate, Regulatory Operations

Breckenridge Pharmaceutical Inc

Berkeley Heights, NJ • Remote

$115K - $135K/yr

Full-time

Medical, Dental, Vision, Retirement

Posted 12 days ago

Job description

About the job


About the Company

Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.



Responsibilities

  • Publishes US Regulatory Submissions to the Food and Drug Administration: NDAs, INDs, ANDAs, Amendments, Supplements, Annual Reports, PADERS, etc. on time in accordance with eCTD submission requirements.
  • Works with the Manager as well as document authors or leads across all disciplines to develop and maintain a comprehensive set of e-submission document templates that are fully compliant with FDA and ICH document requirements.
  • Maintains efficient tracking mechanisms for all regulatory information including the archiving and storage of both electronic and hard copy records.
  • Works on all aspects of document workflows associated with submission authoring, review, compilation and publishing for various submission types.
  • Assists in monitoring and maintains familiarity with evolving and/or new regulatory e-submission requirements and under the direction of the Manager of Regulatory Operations, ensures that all functional disciplines are apprised of the changes and trained accordingly.
  • Helps to author, develop and/or collaborate on SOPs and Work Instructions for the eCTD Publishing and/or Electronic Document Management System.
  • Independently track and manage all correspondence between Breckenridge and government agencies, including phone calls, emails, and relevant documents.
  • Accurately update and maintain trackers, spreadsheets and databases in a timely manner.
  • Meticulously meets corporate and departmental filing objectives with strict adherence to FDA/ICH requirements.
  • Monitors and maintains the highest level of eCTD submission standards.
  • Trains new employees in company submission processes and procedures.
  • Performs other related duties as assigned.


Qualifications

  • Bachelor’s degree in a scientific discipline.


Required Skills

  • Minimum 5 years’ experience in the Pharmaceutical Industry with 3-4 years’ in drug regulatory affairs operations.
  • Knowledge of eCTD publishing systems and standards, EDMS technology and related publishing tools.
  • Working knowledge of US FDA (OGD/CDER) e-submission requirements.
  • Strong written and verbal communication skills.
  • Computer skills required: Microsoft Word, Adobe Acrobat, Microsoft Office Suite, and eCTD publishing software.


Pay range and compensation package

At Breckenridge Pharmaceutical, Inc, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefits programs vary but we offer the following to all BPI team members, regardless of geographic location:

  • Flexible approach to how we work
  • Health benefits and time-off programs
  • Competitive compensation packages
  • The anticipated annual salary for this role is $115,000 - 135,000



Equal Opportunity Statement

Breckenridge Pharmaceutical, Inc is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.



Featured benefits

Medical insurance, Vision insurance, Dental insurance, 401(k), Student loan assistance

Requirements added by the job poster

• 3+ years of work experience with Generic Drugs

• 3+ years of work experience with Electronic Common Technical Document (eCTD)

• 3+ years of work experience with Abbreviated New Drug Application (ANDA)