AstraZeneca has announced a new opportunity for the position of Nonclinical Document Specialist in Bangalore, India. This role is ideal for professionals with experience in document management, regulatory documentation, Veeva Vault, records management, submission publishing, and pharmaceutical data management. Candidates with experience in GxP environments, CTD documentation, archival processes, and electronic document management systems are encouraged to apply.

The selected candidate will support AstraZeneca’s global nonclinical submission team by ensuring high-quality document management, archive coordination, regulatory compliance, and submission readiness for global health authorities.

Job Overview

About AstraZeneca

AstraZeneca is one of the world’s leading science-led biopharmaceutical companies focused on discovering, developing, and commercializing innovative medicines across Oncology, Cardiovascular, Respiratory, Rare Diseases, and Biopharmaceuticals. The company offers excellent career growth, global exposure, and opportunities to work on life-changing medicines.

Key Responsibilities

As a Nonclinical Document Specialist, you will:

• Coordinate nonclinical raw data archival activities.
• Manage document requests and urgent archive retrievals.
• Maintain accurate archive records and metadata.
• Ensure traceability and quality of archived documents.
• Support preparation of regulatory submission documents.
• Edit documents according to AstraZeneca submission standards.
• Maintain submission templates and document content plans.
• Ensure compliance with CTD formatting requirements.
• Work closely with cross-functional global project teams.
• Support electronic document management systems like Veeva Vault.
• Assist in SharePoint-based document workflows.
• Improve operational efficiency using Power Automate.
• Maintain document lifecycle according to GxP standards.

Required Qualifications

Candidates should possess:

• Bachelor’s Degree or equivalent industry experience.
• Good understanding of Records Management or Document Control.
• Experience managing document archives and metadata.
• Strong written and verbal communication skills.
• Knowledge of GxP, ICH Guidelines, and regulated environments.
• Basic understanding of Common Technical Document (CTD).
• Strong Microsoft Word and Excel skills.
• Experience using SharePoint.
• Familiarity with Power Automate.
• Experience with Veeva Vault or similar validated document management systems.

Preferred Qualifications

The following qualifications will be advantageous:

• 3–5 years of pharmaceutical industry experience.
• Knowledge of drug development processes.
• Familiarity with 21 CFR Part 11.
• Experience using:
  • Adobe Acrobat
  • eCTDXPress
  • ISI Toolbox
  • Regulatory publishing software
• Understanding of submission dossier structures.

Required Technical Skills

• Regulatory Documentation
• Document Control
• Records Management
• Veeva Vault
• SharePoint
• Microsoft Office
• Power Automate
• CTD Documentation
• Submission Readiness
• Metadata Management
• Archive Management
• Electronic Document Management Systems (EDMS)
• GxP Compliance
• ICH Guidelines
• Data Integrity

Why Join AstraZeneca?

Working at AstraZeneca provides employees with:

• Competitive salary package
• Hybrid work flexibility
• Global regulatory exposure
• Career advancement opportunities
• Work with innovative medicines
• Collaborative international teams
• Continuous learning programs
• Inclusive workplace culture
• Exposure to regulatory submissions worldwide

Who Should Apply?

This opportunity is ideal for professionals from:

• Regulatory Affairs
• Medical Writing
• Document Control
• Quality Assurance
• Clinical Documentation
• Submission Publishing
• Pharmacovigilance Documentation
• Pharmaceutical Operations
• Electronic Document Management
• Regulatory Publishing

How to Apply

Application Link