AstraZeneca, a renowned global, science-led biopharmaceutical company, is inviting applications for the role of Assistant Manager – Regulatory Affairs at its office in New Delhi, India. With a strong commitment to innovation and a patient-centric approach, AstraZeneca offers an inspiring work environment where professionals can grow, lead, and make a real impact.
About AstraZeneca
AstraZeneca is at the forefront of biopharmaceutical innovation, developing and delivering medicines that transform lives. The company focuses on key therapy areas such as oncology, cardiovascular, renal & metabolism, and respiratory diseases. More than just a pharmaceutical company, AstraZeneca is a place where bold ideas meet global science to improve healthcare outcomes.
Position Overview: Assistant Manager – Regulatory Affairs
📍 Location: New Delhi, India
🆔 Job ID: R-223904
📅 Posted on: July 2, 2025
📆 Application Deadline: July 19, 2025
This position is crucial in supporting AstraZeneca’s regulatory goals by ensuring timely and compliant submission of regulatory dossiers, managing licenses, and interacting with health authorities to facilitate product approvals and lifecycle management.
Key Responsibilities
- Monitor, maintain, and report the status of all product licenses in India
- Implement and execute submission plans for new product approvals and lifecycle maintenance
- Prepare responses to health authority queries and ensure timely archival of documents
- Support regulatory compliance for clinical and commercial operations
- Coordinate with internal teams including Medical, Sales, Legal, QA, and Manufacturing
- Liaise with external agencies like CDSCO, NIB, IPC, CDTL, CDL, and other regulatory bodies
- Contribute to regulatory strategy, intelligence gathering, and impact assessment of new guidelines
- Oversee the submission and compliance processes related to clinical trials and post-marketing studies
- Support audits, CAPA, local FDA license reviews, and artwork compliance
Candidate Requirements
✅ Education:
- M.Pharm, B.Pharm, or M.Sc in a relevant discipline
✅ Experience:
- 3–6 years in Regulatory Affairs within the Indian pharmaceutical industry
- Proficient in dossier compilation and familiar with Indian regulatory guidelines
✅ Skills:
- Strong documentation, project management, and communication skills
- Ability to manage multiple regulatory processes with minimal supervision
- Familiarity with clinical and commercial regulatory requirements
Why Choose AstraZeneca?
- Work with Purpose: Make a real difference in patients’ lives by enabling access to breakthrough medicines
- Inclusive Culture: Thrive in an environment that values collaboration, diversity, and integrity
- Growth Opportunities: Continuous learning, leadership development, and global exposure
- Innovation-Driven: Join a company that champions scientific curiosity and cutting-edge solutions
Join AstraZeneca and be a part of a global team that is pushing the boundaries of science to deliver life-changing treatments.
📢 Apply by July 19, 2025
