AstraZeneca, a global leader in biopharmaceutical innovation, has announced exciting job openings for Regulatory Affairs professionals in Mumbai. These roles offer exceptional opportunities to work on drug approvals, regulatory strategy, PSUR submissions, lifecycle management, and compliance activities aligned with global standards.
If you are looking to build a strong career in Regulatory Affairs, pharmaceutical compliance, and drug approval processes, this is the right time to apply.
This article covers all three openings:
- Executive Assistant – Regulatory Affairs (Two requisitions: R-240766 & R-240764)
- Assistant Manager – Regulatory Affairs (R-240790)
⭐ 1. Executive Assistant – Regulatory Affairs (Mumbai)
Key Responsibilities
- Compile, communicate, and submit responses to Health Authority queries.
- Maintain regulatory documentation and submission trackers.
- Support India-specific artwork development ensuring compliance.
- Assist in preparation and submission of NDAs, GCT applications, site registrations & import licenses.
- Prepare and submit India-specific PSURs based on global PBRER.
- Coordinate lifecycle management activities including renewals and amendments.
- Support audits, deviations, and CAPA implementation.
- Stay updated on regulatory guidelines through active Regulatory Intelligence.
- Manage sample testing documentation for NIBL/CDTL.
Qualifications
- Bachelor’s degree in a relevant field.
- Experience in QA/QC within a pharma manufacturing environment.
- Post-graduate qualification desirable.
Experience is preferred, not mandatory.
No minimum years of experience are mentioned.
It does not require 1–2 years experience like typical junior RA roles.
⭐ 2. Executive Assistant – Regulatory Affairs (Second Listing with Same Job Scope)
Responsibilities, skill sets, and requirements mirror the first Executive Assistant RA listing.
Candidates may apply to either requisition based on suitability.
⭐ 3. Assistant Manager – Regulatory Affairs (Mumbai)
Key Responsibilities
- Develop and implement regulatory strategies for NCEs and accelerated approvals.
- Ensure compliance with Indian regulations and global regulatory policies.
- Prepare and submit regulatory dossiers (NDA, site registration, import license).
- Manage ADC sample testing and registration sample lifecycle.
- Prepare and submit India-specific PSURs.
- Track product license changes and ensure timely renewals.
- Work with Health Authorities for approvals and regulatory updates.
- Conduct competitive intelligence and pipeline analysis.
- Support RA activities for global clinical trials, Phase IV & PMS studies.
Qualifications
- M.Pharm / B.Pharm / M.Sc
- 3–6 years of experience in India Regulatory Affairs
- Strong knowledge of dossier compilation & Indian drug regulations.
🎯 Why Join AstraZeneca Mumbai?
- Work with a global biopharma leader impacting millions of patients.
- Opportunity to contribute to real-world drug development and approvals.
- Dynamic culture focused on collaboration, innovation, and development.
- Exposure to global regulatory frameworks, audits, and compliance systems.
📌 How to Apply
Application Link for Executive Assistant – Regulatory Affairs
Application Link for Executive Assistant – Regulatory Affairs
Application Link for Assistant Manager – Regulatory Affairs
