Regulatory Publishing Specialist

Overview

Perform regulatory publishing, document assembly, electronic submission preparation, and quality control for applications submitted to global regulatory authorities.

What you'll do

• Perform Assembler tasks within the document publishing system, including creating publications, modifying outlines, assigning and transforming documents, and adding cross references.
• Perform publishing tasks within the electronic publishing system, including adding special sheets, applying rules, preparing for publishing, and publishing.
• Perform QC tasks within the electronic publishing system and QC the published output.
• QC materials prepared by the team or client.
• Create, key, and assemble client deliverable documents and submissions using standard word processing or publishing systems and utilities.
• Prepare full application submission builds.
• Troubleshoot issues with eCTD builds and provide guidance to entry-level publishers.
• Provide assistance and guidance to entry-level publishers.
• Review documents for legibility, completeness, and accuracy.
• Log and track regulatory documents, publications, and other relevant materials.
• Organize and compile regulatory documentation, perform pagination, clean-up, and duplication tasks.
• Receive and deliver client information and documents, with significant supervision.
• Provide alternatives for completing assigned tasks.
• Prepare and assemble applications, including INDs, NDAs, ANDAs, DMFs, variations, routine reports, and renewals, for submission to global regulatory authorities.

What you'll need

• 2+ Years Regulatory Publishing Experience.
• BA/BS, with preference given to a science degree.
• Moderate experience in a regulatory environment and experience with electronic publishing of regulatory submissions.
• Good working knowledge of basic computer applications, including MS Word, PowerPoint, and Excel.
• Experience with relevant software such as Extedo’s eCTDManager and eSUBmanager, ISI Toolbox, ISI Publisher, eValidators, Acrobat, Veeva, Documentum, and MS Word.
• Good communication, organizational, and interpersonal skills.
• Ability to work independently and to understand and carry out detailed instruction.
• Attention to the detail and accuracy of information.
• Ability to work concurrently on several projects, each with specific instructions that may differ from project to project.

Nice to have

• Preference given to drug/device/biologic-related industry experience.
• Knowledge of medical/scientific terminology, ICH guidelines and regulations and procedures.
• Knowledge of submission requirements of various markets such as USFDA and EMA.

Details

• Location: Gurugram/Hyderabad.
• Work mode: Hybrid.