Docubridge

About the Company

DocuBridge Specialist: India

About the Role

We are seeking a skilled DocuBridge Specialist with strong experience in DocuBridge and regulatory publishing solutions. The ideal candidate should have hands-on expertise in eCTD submissions.

Responsibilities

• Prepare and publish eCTD and other regulatory submission formats.
• Manage submission lifecycle activities and document compilation.
• Perform quality checks and validation of submission packages.
• Support regulatory content management and document version control.
• Collaborate with Regulatory Affairs, Medical Writing, Quality, and IT teams.
• Troubleshoot DocuBridge application issues and coordinate resolutions.
• Maintain submission records and ensure compliance with regulatory requirements.
• Create SOPs, knowledge articles, and process documentation.
• Support application upgrades, testing, and deployment activities.

Qualifications

• 6-8 years of experience.
• Regulatory Affairs knowledge.
• eCTD publishing.
• Submission lifecycle management.
• Regulatory document management.
• GxP and compliance awareness.

Required Skills

• Strong knowledge of eCTD, CTD, NeeS, and global regulatory submission standards.
• Experience with eCTD lifecycle management, sequence management, and regulatory compliance activities.
• Knowledge of database systems (Oracle, SQL Server).
• Familiarity with regulated environments (Pharma, Life Sciences, BFSI).
• Certification in OpenText Documentum (preferred).
• Experience with global regulatory submissions.
• Familiarity with Veeva Vault, RIM, or other regulatory document management systems.

Pay range and compensation package

Not specified.

Equal Opportunity Statement

We are committed to diversity and inclusivity in our hiring practices.