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Associate Manager - R&D Document Management

Elanco
3-8 years
9 LPA - 16 LPA
Bangalore, India
1 June 22, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Regulatory Affairs, Regulatory Writing, Regulatory Compliance, Global Submissions, eCTD, IND/NDA/BLA Submissions, ICH-GCP, Regulatory Strategy, Regulatory Intelligence, Labeling Strategy.

Associate Manager – R&D Document Management

Location: Bangalore, India
Company: Elanco
Department: Regulatory Affairs / Pharmacovigilance Operations
Employment Type: Full-Time


Role Summary

The Associate Manager – R&D Document Management is responsible for supporting global Regulatory Affairs and Pharmacovigilance functions through effective management of regulatory data, documents, and submission information within Veeva Vault platforms. The role focuses on document governance, metadata quality, data migration, user support, compliance management, and system administration to ensure regulatory information is accurate, complete, and inspection-ready.

This position plays a critical role in maintaining data integrity across global regulatory systems while supporting document migration initiatives, user training, and process standardization.


Key Responsibilities

Regulatory Information Management

  • Perform functional review of regulatory information entered into Vault RIM by global and affiliate users.

  • Ensure regulatory data is entered accurately and complies with established business processes.

  • Verify technical setup and configuration of regulatory records within Vault RIM.

  • Maintain high standards of data integrity and regulatory compliance.

Veeva Vault Administration & User Support

  • Provide functional support to global users for Vault RIM activities.

  • Conduct user training sessions and support calls.

  • Troubleshoot user issues related to regulatory data management.

  • Support publishing teams with document export and submission-related activities.

Document & Metadata Management

  • Ensure document-level metadata is complete, accurate, and compliant.

  • Create, update, and maintain country-specific submission binder templates.

  • Standardize regulatory documentation according to global and local requirements.

  • Maintain consistency across document repositories and regulatory records.

Document Migration & Data Governance

  • Prepare PDF documents for migration activities.

  • Apply OCR, metadata tagging, indexing, and formatting standards.

  • Execute document and data migration activities following approved migration strategies.

  • Support repository management and archival activities.

Quality Review & Verification

  • Conduct migration quality reviews and validation checks.

  • Verify document completeness, accuracy, and integrity post-migration.

  • Ensure regulatory documentation remains inspection-ready.

  • Support continuous quality improvement initiatives.

Training & Knowledge Management

  • Train new team members on:

    • Document Migration Processes

    • Vault RIM Operations

    • Regulatory Documentation Standards

  • Develop process knowledge and support documentation.

  • Promote best practices across the team.

Cross-Functional Collaboration

  • Collaborate with:

    • Regulatory Affairs Teams

    • Pharmacovigilance Teams

    • Publishing Teams

    • Global Affiliates

    • IT & System Support Teams

  • Communicate effectively to resolve migration and data management issues.

  • Support global regulatory operations through proactive stakeholder engagement.

Process Improvement & Compliance

  • Identify opportunities for process optimization.

  • Support implementation of document management best practices.

  • Contribute to a positive and compliant quality culture.

  • Ensure adherence to regulatory and company standards.


Required Qualifications

Education

  • M.Sc. in Life Sciences

  • M.Pharm


Experience

  • 3–8 years of experience in:

    • Regulatory Affairs Operations

    • Regulatory Information Management

    • Document Management

    • Pharmacovigilance Support

    • Data Migration Projects