PHARMAFull-time
Nonclinical Document Specialist
By Admin · Regulatory Affairs
BANGALORE (IN)HYBRIDPOSTED: 8/20/2026
PHARMAFull-time
HIRING ORGANIZATIONASTRAZENECAPharmaceuticals / Biopharmaceuticals / Healthcare
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Nonclinical Data Archival & Repository Management: Manage and coordinate the archival of primary raw data, critical biological specimens, and nonclinical study records in compliance with operational procedures and chain of custody standards. Maintain record accuracy, indexing, metadata quality, and traceability in internal databases.
Submission Document Readiness: Edit nonclinical submission documents to ensure conformance with AstraZeneca house style, regulatory standards, and CTD requirements. Contribute to the preparation and maintenance of submission document content plans and templates.
Cross-Functional Stakeholder Communication: Act as an advisor on nonclinical submission technical requirements to project teams, internal groups, and external partners across geographically dispersed matrix teams. Manage urgent data retrieval requests and queries.
Process Optimization & Automation: Leverage tools like Microsoft Power Automate, SharePoint, and validated Electronic Document Management Systems (EDMS) to simplify, automate, and standardize document control and archival processes.
Technical & Domain Standards
Regulatory Compliance & EDMS: Working knowledge of GxP, ICH guidelines, CTD content structures, and experience using validated document platforms such as Veeva Vault.
Technical Productivity Tools: High proficiency in Microsoft Word, Excel, SharePoint, Adobe Acrobat, and basic workflow automation (Power Automate).
Leadership & Impact
Document Quality Governance: Ensure high technical quality, data integrity, and strict regulatory conformance for nonclinical dossiers supporting clinical trial and marketing applications.
Process Support & Coordination: Streamline document delivery across global R&D project teams, ensuring seamless transition from primary raw data to submission-ready assets.
Benefits & Total Rewards
Hybrid Work Framework: Minimum of 3 days per week working on-site in Bangalore with flexible working arrangements.
Total Rewards & Culture: Competitive pharmaceutical industry compensation, comprehensive health and wellness benefits, continuous learning opportunities, and an inclusive global R&D environment.
REQUIRED VERIFIED SKILLS
Document Control
Records Management
Nonclinical Data Archival
CTD Standards
Veeva Vault
GxP Compliance
Microsoft Power Automate
SharePoint
Adobe Acrobat
Metadata Quality
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
AstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development, and commercialisation of prescription medicines. The company operates in various therapeutic areas, including Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. AstraZeneca is committed to pushing the boundaries of science to deliver life-changing medicines and improve patient outcomes worldwide.
TEAM SIZE: 89,000+ employees
INDUSTRY: Pharmaceuticals / Biopharmaceuticals / Healthcare
RECOMMENDED TRAINING
1/3
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