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Ectd Publishing Jobs (NOW HIRING)

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 ...

Bristol-Myers Squibb

$150 - $182/hr

Experience with eCTD publishing solutions and regulatory submission workflows.* Experience supporting Veeva RIM Publishing implementation preferred.**Skills and Qualifications*** Strong understanding ...

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How much do ectd publishing jobs pay per hour?

As of Aug 21, 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 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 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 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.

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Ectd Publishing jobs near you
Infographic showing various Ectd Publishing job openings in the United States as of August 2026, with employment types broken down into 2% Internship, 85% Full Time, 9% Part Time, 1% Temporary, and 3% Contract. Highlights an 76% Physical, 5% Hybrid, and 19% Remote job distribution, with an average salary of $48,522 per year, or $23.3 per hour.

Senior Associate, Regulatory Operations

Breckenridge Pharmaceutical Inc

Berkeley Heights, NJ • Remote

$115K - $135K/yr

Full-time

Medical, Dental, Vision, Retirement

Posted 24 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)