Senior Regulatory Publishing Specialist

1 month ago


Delhi, Delhi, India TransPerfect Full time

**Job Summary:**

We are seeking a skilled Senior Regulatory Publisher to join our team at TransPerfect. This is an exciting opportunity to work with Regulatory Affairs and publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standards.

About the Role:

The successful candidate will be responsible for working closely with Regulatory Affairs to ensure compliance with government acts and regulations. This includes implementing publishing processes across multiple teams, developing a thorough understanding of all aspects of the publishing software, tools, process, and output requirements, and performing eCTD readiness/pre-publishing tasks.

Responsibilities:

  • Publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standards
  • 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)
  • Complete high-quality submissions following regulatory guidelines and internal processes within timelines
  • Ensure consistency across regulatory submission documents following the regulatory style guide
  • Perform publishing QC tasks within the electronic publishing system and QC of the published output to ensure high submission quality

Requirements:

  • Minimum 4+ years' experience in eCTD Regulatory Publishing required
  • Demonstrated attention to detail, ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe
  • Excellent communication and organizational skills, as well as a high level of proficiency with problem-solving, conflict resolution, negotiation, and team-building skills

What We Offer:

  • An estimated salary of $120,000 per year, commensurate with experience
  • A comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off
  • A dynamic and supportive work environment with opportunities for professional growth and development


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