Experience Required: 3–8 Years

Department: Regulatory Affairs

Reporting To: Regulatory Operations Manager / Head – Regulatory Affairs

About The Role

We are looking for an experienced and detail-oriented Regulatory Publishing Specialist to support the preparation, compilation, publishing, validation, submission, archiving, and lifecycle management of global regulatory submissions.

The role involves working with eCTD publishing tools such as DocuBridge and Lorenz and ensuring that regulatory submissions comply with applicable requirements of FDA, EMA, ICH, and other global regulatory agencies.

The ideal candidate should have robust technical knowledge of regulatory publishing and submission standards, excellent attention to detail, strong troubleshooting skills, and the ability to coordinate effectively with cross-functional teams to deliver high-quality submissions within defined timelines.

Key Responsibilities

Regulatory Submission Publishing

• Publish initial applications, supplements, variations, annual reports, renewals, responses,



and lifecycle maintenance submissions using DocuBridge, Lorenz, or equivalent publishing tools.
• Compile, assemble, and publish regulatory submission packages in accordance with regional and global regulatory requirements.
• Ensure accurate and timely delivery of electronic submissions to regulatory authorities.
• Support the complete lifecycle management of eCTD submissions, including sequences, replacements, amendments, and withdrawals.
• Verify that all submission components are complete and correctly placed before dispatch.

eCTD Compliance & Quality Management

• Ensure regulatory submissions comply with FDA, EMA, ICH, and applicable regional eCTD standards.
• Perform technical validation and quality-control checks before submission.
• Review submission structures, metadata, hyperlinks, bookmarks, file formats, naming conventions, and document placement.
• Identify, investigate, and rectify technical validation errors be

📌 Regulatory Publishing Specialist – Regulatory Affairs (Gurugram)
🏢 DDReg Pharma
📍 Gurugram