Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Associate Manager - R&D Document Management

Elanco
3-8 years
INR 8 LPA – 18 LPA
Bangalore, India
1 June 23, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding

Associate Manager – R&D Document Management

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

Role Summary

The Associate Manager – R&D Document Management is responsible for supporting global Regulatory Affairs and Pharmacovigilance teams through document management, regulatory information management, data migration, and system administration activities. The role focuses on maintaining data quality and compliance within Veeva Vault RIM and Vault Clinical systems, supporting global regulatory submissions, managing document migration projects, and ensuring regulatory documentation accuracy and integrity.

Key Responsibilities

Regulatory Information Management

  • Review and validate regulatory information entered into Vault RIM.

  • Ensure regulatory data is accurately configured within the system.

  • Support global and affiliate users with Vault RIM processes.

  • Provide guidance on regulatory information entry and system usage.

  • Ensure metadata accuracy at document level.

Veeva Vault RIM Support

  • Support:

    • Vault RIM

    • Vault Clinical

    • Regulatory Submission Management

  • Assist publishing teams with submission-related activities.

  • Create and maintain country-specific submission binder templates.

  • Ensure compliance with local regulatory requirements.

Document Management & Migration

  • Prepare and standardize documents for migration.

  • Apply:

    • OCR Processing

    • Metadata Mapping

    • Document Formatting Standards

  • Execute document and data migrations into approved repositories.

  • Maintain document integrity during migration activities.

  • Support migration strategy implementation.

Quality Control & Verification

  • Perform document migration verification.

  • Conduct quality reviews to ensure:

    • Data Accuracy

    • Completeness

    • Regulatory Compliance

    • Metadata Integrity

  • Identify and resolve document management issues.

Training & Team Support

  • Train new team members on:

    • Document Migration Tools

    • Vault Systems

    • Document Management Processes

  • Support knowledge sharing and process improvement initiatives.

  • Promote a collaborative and positive work environment.

Stakeholder Management

  • Collaborate with:

    • Regulatory Affairs Teams

    • Pharmacovigilance Teams

    • Publishing Teams

    • Global Affiliates

    • System Users

  • Resolve document management and migration challenges.

  • Support global regulatory operations.

Compliance & Documentation

  • Ensure compliance with:

    • Regulatory Documentation Standards

    • Data Governance Requirements

    • Company SOPs

    • Quality Management Processes

  • Maintain audit-ready documentation and records.

Required Qualifications

Education

  • M.Sc in Life Sciences
    OR

  • M.Pharm

Experience

  • 3–8 years of experience in:

    • Regulatory Affairs Operations

    • Document Management

    • Regulatory Information Management

    • Pharmacovigilance Documentation

    • Data Migration Activities