# Document Specialist

> VCLS · Bengaluru, India (Hybrid) · — · Posted 2026-06-23

**Workplace:** hybrid

**Department:** Regulatory Strategy

## Description

-   Format regulatory documents according to company and regulatory agency standards
-   Create and maintain document templates, style guides and formatting standards
-   Create and maintain submission-ready PDFs including Bookmarks, Hyperlinks, Table of Contents, page numbering, metadata etc.
-   Perform quality control (QC) reviews of regulatory documents before publishing and submission.
-   Ensure compliance with CTD/eCTD, NeeS, and eDok formatting requirements.
-   Support preparation of dossiers for submissions to agencies such as US FDA, EMA, MHRA, Swissmedic and Health Canada
-   Manage document life cycle activities, version control and archival
-   Coordinate with Regulatory affairs, medical writing, CMC, Clinical and Quality teams to obtain and process submission documents
-   Support Publishing teams during dossier compilation and submission activities
-   Maintain submission trackers, regulatory archives and document repositories
-   Monitor evolving regulatory submission standards and provide guidance to stakeholders
-   Participate in the update of internal eCTD Distinct Technical Procedures (DTPs)
-   Provide training and mentoring to document/eCTD Specialists (when applicable)
-   Interact frequently with clients during project execution and discuss/challenge as necessary
-   Proactively communicate with colleagues at all levels to ensure mutual exchange of information
-   Collaborate with all regulatory teams to ensure good coordination of activities and a coherent clinical program
-   Liaise with sponsor, regulatory authorities and/or service providers when appropriate
-   Raise awareness of potential opportunities regarding transversal activities (eg. for other Service Units and/or Areas of Expertise and/or Geographical Areas)
-   Proactively contribute to knowledge sharing within VCLS

## Requirements

-   Life Science Graduate + solid academic background in Life Sciences;
-   Proven experience in document formatting, regulatory publishing or operations
-   Experience supporting eCTD, NeeS or eDok submissions
-   Knowledge of document management systems and quality-controlled environments
-   Strong knowledge of Microsoft word formatting
-   Experience in a consulting environment is a plus;
-   Good command of MS Office (Word, Excel, PowerPoint);
-   Excellent attention to detail and organizational skills
-   Strong problem-solving skills, ability to work under tight deadlines and manage multiple projects
-   Demonstrated ability to manage and build relationships with colleagues and regulatory authorities

## Apply

[Apply at VCLS](https://apply.workable.com/vcls/j/1C4E7BF87F/apply)

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