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Introduction
Senior-level regulatory roles in the pharmaceutical industry offer the opportunity to influence global drug development and submission strategies. The Associate Director Non Clinical Data and Documents job at AstraZeneca is a high-impact leadership role focused on regulatory operations, document management, and submission excellence. This position is ideal for experienced professionals who want to lead teams, manage complex regulatory submissions, and contribute to bringing innovative medicines to patients worldwide.
Job Overview
| Details | Information |
|---|---|
| Job Title | Associate Director – Non Clinical Data and Documents |
| Company Name | AstraZeneca |
| Location | Bangalore, India |
| Employment Type | Full-Time |
| Department | Regulatory Operations / Document Management |
| Experience Required | 8+ Years |
| Education | Master’s / PhD in Life Sciences or related field |
| Salary | As per company norms |
Company Overview
AstraZeneca is a globally renowned biopharmaceutical organization focused on developing innovative medicines across oncology, cardiovascular, respiratory, and other therapeutic areas. Known for its strong research pipeline and advanced regulatory capabilities, AstraZeneca offers a collaborative environment where professionals can contribute to life-changing therapies while advancing their careers.
Job Location & Employment Type
This role is based in Bangalore, India, with a hybrid work model requiring a minimum number of in-office days per week. It is a full-time leadership position within the regulatory operations function.
Open Positions / Department Details
- Department: Regulatory Operations / Non-Clinical Data & Document Management
- Role Level: Associate Director (Leadership Role)
- Focus Area: Regulatory submissions, SEND data, document formatting, and publishing
Key Roles & Responsibilities
As an Associate Director, you will lead regulatory document operations and ensure high-quality submission processes. Key responsibilities include:
- Leading and managing a team of regulatory operations professionals
- Planning, prioritizing, and tracking submission deliverables
- Overseeing document management, quality control, and archival processes
- Ensuring compliance with Submission Ready Standard (SRS)
- Enforcing formatting and house style standards for regulatory submissions
- Managing validation errors and implementing corrective actions
- Overseeing publishing tools like Veeva Vault RIM for eCTD submissions
- Ensuring compliance with GxP and data integrity principles
- Collaborating with stakeholders including SEND and regulatory experts
- Monitoring KPIs such as first-time-right rates and validation trends
- Supporting non-clinical data archiving and retrieval processes
- Driving continuous improvement in regulatory workflows and SOPs
Eligibility Criteria
Education
- Master’s degree in Life Sciences, Pharmacy, Information Management, or related field
- PhD or equivalent qualification preferred
Experience
- Minimum 8 years of experience in regulatory operations or document management
- At least 3 years of leadership or team management experience
Skills Required
- Expertise in document management systems (e.g., Veeva Vault RIM)
- Strong understanding of eCTD submission processes
- Knowledge of Submission Ready Standard (SRS)
- Experience with validation rules and error management
- Advanced document formatting and publishing skills (Word/PDF)
- Familiarity with GxP compliance and audit readiness
- Leadership, coaching, and team management skills
- Strong communication and problem-solving abilities
Salary & Benefits
- Salary: As per company norms (senior leadership compensation)
- Opportunity to work in a global regulatory leadership role
- Exposure to advanced submission technologies and processes
- Career growth within a top-tier pharmaceutical company
- Access to learning programs and regulatory training academies
- Collaborative and innovation-driven work culture
Selection Process
The recruitment process typically includes:
- Application screening
- HR discussion
- Technical/functional interviews
- Leadership interview
- Final offer
How to Apply
Interested candidates can apply through the online application process via AstraZeneca’s official careers portal or job listing page.
Important Dates
- Application Deadline: May 9–10, 2026
Why Apply for This Job?
The Associate Director Non Clinical Data and Documents job at AstraZeneca offers a unique opportunity to lead regulatory operations at a global scale. Here’s why this role stands out:
- Leadership role with strategic impact on regulatory submissions
- Opportunity to work with advanced technologies like Veeva Vault
- Involvement in global drug development and submission processes
- Strong career growth and leadership development programs
- Exposure to international regulatory standards and health authorities
This role is ideal for experienced professionals aiming to move into senior leadership within regulatory affairs and operations.
FAQs
1. Who can apply for this role?
Candidates with a Master’s or PhD in life sciences and 8+ years of regulatory experience can apply.
2. Is leadership experience required?
Yes, at least 3 years of team leadership or management experience is required.
3. What tools are required for this role?
Experience with Veeva Vault RIM, eCTD publishing tools, and document management systems is essential.
4. What is the job location?
The role is based in Bangalore, India.
5. How can I apply for this job?
You can apply online through AstraZeneca’s official careers portal.
Conclusion
The Associate Director role at AstraZeneca is a prestigious opportunity for experienced regulatory professionals to lead high-impact projects and teams. With global exposure, advanced tools, and strong career growth prospects, this position is ideal for those looking to advance into senior leadership roles in regulatory operations. Apply soon to take the next step in your career.
Disclaimer
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