Regulatory Publishing Specialist

3 days ago

Pune, Maharashtra, India TransPerfect Full time

Job Title: Regulatory Publisher

About the Role:

We are seeking a highly skilled Regulatory Publisher to join our team at TransPerfect. As a key member of our publishing department, you will be responsible for publishing clinical study reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standards.

Main Responsibilities:

  • Publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standards.
  • Report directly to the Team Manager on all team and client issues, project work, project deliverables associated timelines, ensuring SLAs are satisfied and deliver reporting – daily, weekly, or monthly.
  • Develop a thorough understanding of all aspects of the publishing software, tools, process, and output requirements.
  • Perform eCTD readiness/pre-publishing tasks (i.e., formatting, bookmarking, and document navigation).
  • Perform tasks within the publishing system (creating eCTD submissions, lifecycle management, assigning documents, adding cross-reference hyperlinks).
  • Complete high-quality submissions following regulatory guidelines and internal processes within timeliness.
  • Ensure consistency across regulatory submission documents following the regulatory style guide.
  • Maintain knowledge of current regional regulations in regard to application format.
  • Understand, interpret, and apply Agency regulations and guidelines related to eCTD submissions.
  • Dispatch submissions to Regulatory Authorities via agency portal, through customers or directly.
  • Build a good working partnership with Service Desk and Solutions Engineering Teams to ensure efficiency for project deliverables and timelines are adhered and SLAs are kept.
  • Participate in submission team meetings to plan and track submissions and relevant documents as assigned.
  • Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor.

Requirements:

The ideal candidate will have a minimum Bachelor's degree or its equivalent and 0 to 2 years of experience in eCTD Regulatory Publishing. Strong attention to detail, problem-solving abilities, adaptability, technical writing and documentation knowledge, strong technical aptitude, confidence, and assertiveness are also required.

Working at TransPerfect:

TransPerfect is a leading provider of global content services, including translation, interpretation, subtitling, and multimedia localization. We offer competitive salaries, excellent benefits, and a dynamic work environment. The estimated salary for this position is $65,000 - $85,000 per year, depending on location and experience.

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