AstraZeneca is a global, science-led biopharmaceutical company focused on discovering, developing, and commercializing prescription medicines. With a strong pipeline of innovative treatments, we aim to improve patient health worldwide. Our inclusive and diverse work environment fosters creativity, collaboration, and cutting-edge research to deliver life-changing medicines.
Job Description
AstraZeneca is seeking a Nonclinical Document Specialist to join our Nonclinical Submission Group in Bangalore. In this role, you will ensure the technical quality and timely delivery of nonclinical regulatory submissions. You will collaborate with internal and external teams to provide expert guidance on submission requirements, document formatting, and compliance with global regulatory standards.
Key Responsibilities:
✔ Generate high-quality nonclinical submission documents in compliance with regulatory standards.
✔ Apply proper naming conventions and structure for regulatory submissions.
✔ Import and manage submission documents, including referenced literature and reference lists.
✔ Edit and format documents to meet AstraZeneca’s submission-ready standards.
✔ Contribute to the development and maintenance of document templates.
✔ Collaborate with cross-functional global teams to streamline submission processes.
✔ Ensure compliance with ICH, GxP, and CTD (Common Technical Document) guidelines.
✔ Utilize Veeva Vault, ISI Toolbox, Adobe Acrobat, and eCTDXPress for document management.
Essential Skills & Qualifications:
✅ Bachelor’s degree or equivalent industry experience.
✅ 3-5 years of experience in pharmaceutical document management systems (e.g., Veeva Vault).
✅ Strong knowledge of nonclinical dossier structures and e-submission requirements (US, EU, etc.).
✅ Proficiency in Microsoft Word, SharePoint, and Adobe Acrobat.
✅ Experience with automation tools (Power Automate) is a plus.
✅ Understanding of CFR 21 Part 11 and global regulatory standards.
✅ Excellent communication and project management skills.
Why Join AstraZeneca?
🔹 Work in a dynamic, science-driven environment with global impact.
🔹 Hybrid work model (minimum 3 days/week in-office).
🔹 Career growth opportunities and continuous learning.
🔹 Inclusive workplace culture that values diverse perspectives.
