Regulatory Submission Jobs 2025 Hiring at AstraZeneca Nonclinical Document Specialist Role
AstraZeneca, a global leader in biopharmaceutical innovation, has announced a job opening for the role of Nonclinical Document Specialist at its Bangalore location. This opportunity is ideal for professionals with 3–5 years of experience in pharmaceutical regulatory submissions and document management systems. Regulatory Submission Jobs 2025 Hiring
The role supports AstraZeneca’s global regulatory affairs and nonclinical submission efforts, contributing to the preparation and delivery of technically sound regulatory dossiers in accordance with international guidelines.
Job Overview
| Key Details | Description |
|---|---|
| Organization Name | AstraZeneca |
| Job Role | Nonclinical Document Specialist |
| Department | Nonclinical Submission Group |
| Location | Bangalore, India |
| Mode of Work | Hybrid (minimum 3 days/week in-office) |
| Experience Required | 3 to 5 years |
| Qualification | B.Pharm, M.Pharm, M.Sc or equivalent industry experience |
| Salary | Not disclosed |
| Application Mode | Online Application |
| Job Verified | Yes |
| Posted Date | May 27, 2025 |
About AstraZeneca Regulatory Submission Jobs 2025 Hiring
AstraZeneca is a science-led global biopharmaceutical company renowned for developing, producing, and delivering life-changing medicines. Operating in over 100 countries, the company focuses on therapeutic areas such as oncology, cardiovascular, renal, respiratory, and immunology. AstraZeneca combines cutting-edge research with a people-focused workplace, promoting a collaborative and inclusive environment that drives innovation. Regulatory Submission Jobs 2025 Hiring
Position Summary: Nonclinical Document Specialist
This role is part of AstraZeneca’s Nonclinical Submission Group in the Global Regulatory Affairs division. The selected candidate will be responsible for compiling and managing nonclinical submission documents that comply with global regulatory requirements, including ICH, GxP, and CTD standards. Regulatory Submission Jobs 2025 Hiring
Key Responsibilities
- Prepare and format high-quality nonclinical regulatory documents.
- Apply accurate naming conventions and maintain document structure.
- Manage submission components, including cited literature and references.
- Ensure submission readiness by editing and formatting content to company standards.
- Contribute to the development and improvement of regulatory templates.
- Collaborate with cross-functional teams across geographies.
- Use document systems like Veeva Vault, eCTDXPress, ISI Toolbox, and Adobe Acrobat.
- Ensure compliance with global e-submission requirements (e.g., US FDA, EMA).
- Understand and apply principles from 21 CFR Part 11.
Required Qualifications and Skills
- Bachelor’s degree in Pharmacy, Life Sciences, or related field (or equivalent experience).
- Minimum 3–5 years of experience in pharmaceutical documentation or regulatory submissions.
- Expertise in nonclinical dossier structures and e-submission systems.
- Familiarity with Veeva Vault and other document management platforms.
- Strong command of Microsoft Word, SharePoint, and Adobe Acrobat.
- Experience with automation tools like Power Automate is a plus.
- Strong understanding of global regulatory frameworks.
- Good communication and time management skills.
Why Work at AstraZeneca?
- Be part of a mission-driven organization with a global healthcare impact.
- Work in a hybrid model, balancing in-office collaboration and remote flexibility.
- Join a team that values career growth, continuous learning, and work-life balance.
- Experience a diverse and inclusive culture that fosters creativity and innovation.
- Contribute to challenging projects at the forefront of drug development.
How to Apply
Interested candidates can apply online through AstraZeneca’s official careers portal.
Application Link:
(Search for “Nonclinical Document Specialist – Bangalore”)
Ensure your resume is updated and clearly reflects your relevant experience in regulatory documentation, dossier structuring, and pharmaceutical industry tools. Regulatory Submission Jobs 2025 Hiring
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Final Words
The Nonclinical Document Specialist role at AstraZeneca is an excellent career opportunity for professionals with experience in regulatory documentation and global submission processes. If you’re looking to work in a fast-paced, science-driven environment that values innovation and collaboration, this position could be a perfect match. Regulatory Submission Jobs 2025 Hiring
Apply today and be part of a company that is redefining the future of medicine and transforming millions of lives around the world.
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