AstraZeneca has announced a new opportunity for a Nonclinical Document Specialist in Bangalore. This full-time pharmaceutical job is suitable for candidates with experience or knowledge in records management, document control, electronic document management systems, nonclinical submissions, CTD documentation, GxP and regulatory documentation.

The Nonclinical Document Specialist will join AstraZeneca’s Nonclinical Submission group and support the technical quality, repository management, archival and delivery of nonclinical data and documents used for regulatory submissions.

Candidates with a Bachelor’s degree or equivalent industry-relevant experience can be considered. Knowledge of Veeva Vault, SharePoint, Microsoft Word, Excel, Power Automate, CTD, GxP and ICH principles can be particularly valuable.

Job Overview

About the Role

As a Nonclinical Document Specialist at AstraZeneca, you will support nonclinical data and documentation throughout the product lifecycle.

The position is responsible for the technical quality, repository management and delivery of primary raw data, critical biological specimens and nonclinical submission data.

You will also coordinate data archival activities and provide guidance to project teams, internal stakeholders and external partners regarding technical requirements for nonclinical regulatory submissions supporting clinical trial and marketing applications.

The role combines document management, records management, regulatory submission support, data quality and electronic document management responsibilities.

Key Responsibilities

Selected candidates will be expected to:

• Support archival processes for primary raw nonclinical data.
• Manage archive requests and coordinate urgent document or data requirements.
• Maintain effective communication with internal and external stakeholders.
• Ensure appropriate management of forms and chain-of-custody requirements.
• Coordinate internal delivery arrangements through established operational processes.
• Oversee archival data management activities within relevant databases.
• Maintain accurate, complete and consistent records in archive management systems.
• Support indexing, metadata quality, traceability and document retrieval.
• Edit nonclinical documents for regulatory submissions.
• Ensure documents comply with AstraZeneca house style and submission-ready standards.
• Support compliance with applicable regulatory agency requirements.
• Prepare and maintain submission document content plans.
• Support the development and maintenance of document templates.
• Provide technical guidance concerning nonclinical submission requirements.
• Work with geographically dispersed and cross-functional global teams.

Qualification – Which Degree Can Apply?

AstraZeneca specifies:

Bachelor’s degree or equivalent industry-relevant experience.

The job description does not restrict eligibility to a particular Bachelor’s discipline.

Candidates from pharmaceutical, life sciences, scientific, information/document management or other relevant backgrounds may therefore consider applying if their education and professional experience align with the required document management and regulatory skills.

Applicants should not assume eligibility solely based on degree title; AstraZeneca will evaluate the overall match against the role requirements.

Essential Skills and Experience

Candidates should have a good understanding of records management or document control principles, particularly within regulated or process-driven environments.

Important skills include:

• Records management
• Document control
• Archive management
• Data management
• Accurate indexing and metadata management
• Data quality and traceability
• Document retrieval
• GxP awareness
• ICH principles
• Basic CTD knowledge
• Regulatory document formatting
• Microsoft Word
• Microsoft Excel
• SharePoint
• Power Automate
• Electronic document management systems
• Veeva Vault
• Written and verbal communication
• Stakeholder management
• Priority and project management

Candidates should also be comfortable communicating with cross-functional and geographically dispersed global teams.

Experience Required

AstraZeneca lists 3–5 years of industry experience in validated electronic data management systems as desirable, rather than under the essential requirements.

Therefore, the vacancy should not be presented as strictly requiring 3–5 years of experience.

However, applicants with previous pharmaceutical industry experience involving document management, records management, regulatory documentation, archives, Veeva Vault or validated electronic data management systems are likely to have stronger alignment with the position.

Desirable Skills

Additional experience or knowledge that can strengthen an application includes:

• 3–5 years of industry experience with validated electronic data management systems
• Basic understanding of the drug development lifecycle
• Knowledge of 21 CFR Part 11 principles
• Understanding of other relevant global regulatory standards
• Adobe Acrobat experience
• Database tool experience
• Understanding of regulatory submission dossier structures
• Advanced understanding of common regulatory file formats
• ISI Toolbox
• Adobe Acrobat
• eCTDXPress or similar publishing tools

Knowledge of Veeva Vault and SharePoint

Experience with Veeva Vault is particularly relevant because AstraZeneca specifically mentions experience working with validated electronic document management systems in a pharmaceutical environment.

Candidates with exposure to SharePoint, Veeva Vault, document repositories, archival databases, EDMS platforms or regulatory document management systems should highlight these skills clearly in their resume.

CTD and Regulatory Submission Knowledge

The role requires a basic understanding of the Common Technical Document (CTD) and its content and formatting standards.

Candidates with experience in areas such as:

• Regulatory Affairs
• Regulatory Operations
• Regulatory Publishing
• Document Management
• Submission Management
• Nonclinical Documentation
• Clinical Documentation
• Records Management

may find their existing skills transferable to this position.

Is This Job Suitable for Freshers?

This position is not explicitly advertised as a fresher role.

Although the essential qualification states a Bachelor’s degree or equivalent industry-relevant experience, the responsibilities require familiarity with records/document management, regulated systems and pharmaceutical documentation.

Additionally, AstraZeneca lists 3–5 years of industry experience in validated electronic data management systems as desirable.

Fresh graduates who meet relevant skills can review and apply, but candidates with applicable document management or pharmaceutical industry experience are likely to be more closely aligned with the job description.

Work Model

The position is based in Bangalore, India.

AstraZeneca states that employees are expected to work a minimum of three days per week from the office on average, while maintaining flexibility depending on individual and business requirements.

Why Consider This Opportunity?

The AstraZeneca Nonclinical Document Specialist role offers exposure to several important areas of pharmaceutical R&D and regulatory operations, including:

• Global pharmaceutical drug development
• Nonclinical regulatory submissions
• Document and records management
• Regulatory documentation
• Electronic document management systems
• Data archival and traceability
• CTD documentation
• GxP-regulated processes
• Cross-functional global project teams

This can be particularly relevant for professionals interested in developing careers in regulatory operations, regulatory submissions, document management, records management and pharmaceutical R&D operations.

How to Apply

Application Link