Docubridge Specialist | Remote opportunity | Client: Tcs

Dear Candidate,

We are hiring for MNC client PAN India Remote opportunity.

Job Role: DocuBridge Specialist

Experience: 8+ Years

Location: PAN India / Remote

Job Summary:

We are looking for a DocuBridge Specialist with strong experience in regulatory publishing and eCTD submissions. The candidate will be responsible for preparing, publishing, validating, and maintaining regulatory submissions in compliance with global health authority requirements.

Key Responsibilities:

• Prepare, compile, validate, and publish eCTD/NeeS submissions using DocuBridge.
• Perform document formatting, hyperlinking, bookmarking, and QC.
• Troubleshoot DocuBridge publishing and validation issues.
• Ensure compliance with FDA, EMA, PMDA, and other regulatory requirements.
• Manage submission lifecycle activities including amendments and updates.
• Collaborate with Regulatory Affairs, Regulatory Publishing, and Quality teams.
• Maintain SOPs, documentation, and regulatory publishing best practices.

Mandatory Skills:

• Hands-on DocuBridge experience.
• Strong eCTD publishing experience.
• Knowledge of regulatory submission processes.
• Experience with PDF optimization, XML backbone, and validation.
• Knowledge of global health authority requirements.
• Experience with Veeva Vault / Documentum or similar EDMS/RIM systems.

Industry: Pharmaceutical / Biotechnology / CRO / Life Sciences.

Interested candidates can share profile on divya,[email removed]