DocuBridge Specialist

About the Company

CosMicIT is inviting applications for the role of DocuBridge Specialist based in India. The position involves hands-on management and expertise in DocuBridge and regulatory publishing processes.

About the Role

The role requires an experienced professional skilled in eCTD submissions and regulatory document management. The candidate will collaborate with multiple departments to ensure regulatory submissions meet compliance requirements.

Key Responsibilities

• Prepare and publish eCTD and other regulatory submission formats accurately.
• Manage all activities related to submission lifecycle and compile required documents.
• Perform meticulous quality checks and validate submission packages before delivery.
• Maintain regulatory content management and oversee document version control.
• Work closely with Regulatory Affairs, Medical Writing, Quality Assurance, and IT teams for smooth operations.
• Identify and resolve DocuBridge application issues in coordination with support teams.
• Maintain detailed records of submissions ensuring compliance with regulatory standards.
• Create and update Standard Operating Procedures, knowledge bases, and process documentation.
• Assist in application upgrades, perform testing, and support deployment tasks.

Required Qualifications

• 6 to 8 years of relevant experience in regulatory submissions and publishing.
• Sound understanding of Regulatory Affairs processes.
• Experience in publishing and managing eCTD submissions.
• Comprehensive knowledge of submission lifecycle management and regulatory document handling.
• Awareness of GxP standards and regulatory compliance requirements.

Essential Skills

• In-depth knowledge of eCTD, CTD, NeeS, and global regulatory submission standards.
• Experience with eCTD lifecycle management, sequence management, and ensuring regulatory compliance.
• Familiarity with database systems such as Oracle and SQL Server.
• Experience working within regulated environments including Pharmaceuticals, Life Sciences, and Banking & Financial Services Industries.
• Certification in OpenText Documentum is preferred.
• Experience with global regulatory submission procedures.
• Knowledge of regulatory document management tools like Veeva Vault, RIM, or equivalents.

Additional Information

The compensation package details are not disclosed. The organization emphasizes commitment to diversity and equal opportunity employment practices.