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Senior Ectd Publisher information

What is the difference between Senior Ectd Publisher vs Ectd Publisher?

AspectSenior Ectd PublisherEctd Publisher
CredentialsTypically requires experience in eCTD publishing, life sciences, and related certificationsRequires similar experience and certifications, but less leadership responsibility
Work EnvironmentWorks in pharmaceutical or biotech companies, often in regulatory teamsSimilar environment, often as part of regulatory or publishing teams
ResponsibilitiesLeads publishing projects, mentors junior staff, ensures compliancePerforms publishing tasks, supports project needs, follows established procedures

The main difference between a Senior Ectd Publisher and an Ectd Publisher is the level of responsibility. Senior roles typically involve leadership, mentorship, and project oversight, while Ectd Publishers focus on executing publishing tasks. Both roles require similar qualifications and work in comparable environments within the pharmaceutical and biotech industries.

What are some common challenges Senior eCTD Publishers face when managing multiple regulatory submissions simultaneously?

Senior eCTD Publishers often juggle several regulatory submissions at once, each with unique timelines, formatting requirements, and jurisdictional regulations. Coordinating with various cross-functional teams—such as regulatory affairs, clinical, and quality assurance—can add complexity, especially when gathering final documents and resolving last-minute changes. Effective time management, meticulous attention to detail, and strong communication skills are essential to ensure all submissions are compliant, accurate, and delivered on time.

What is a Senior eCTD Publisher?

Senior eCTD Publishers are specialized professionals in the pharmaceutical and biotechnology industries who are responsible for preparing, compiling, and submitting electronic Common Technical Document (eCTD) submissions to regulatory agencies like the FDA and EMA. They ensure that all documents and data meet strict regulatory requirements for format, structure, and quality. In addition to technical publishing tasks, they often lead submission projects, coordinate with cross-functional teams, and provide expertise in regulatory submission standards and software tools.

What are the key skills and qualifications needed to thrive as a Senior eCTD Publisher?

To thrive as a Senior eCTD Publisher, you need in-depth knowledge of regulatory submissions, eCTD structure, and relevant industry guidelines, typically backed by experience in regulatory affairs or pharmaceutical publishing. Proficiency with eCTD publishing software (such as Lorenz DocuBridge or Extedo), document management systems, and familiarity with FDA/EMA submission portals is essential. Attention to detail, strong organizational skills, and effective communication help ensure accuracy and collaboration within cross-functional teams. These skills and qualifications are vital for ensuring compliant, timely, and error-free submissions to regulatory authorities.
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Senior Ectd Publisher jobs near you
Infographic showing various Senior Ectd Publisher job openings in the United States as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% Remote job distribution.

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)