AstraZeneca, a world-leading biopharmaceutical company, is inviting applications for the role of Executive – Regulatory Affairs in Mumbai. This opportunity is ideal for professionals skilled in regulatory submissions, compliance, PSUR management, and lifecycle activities. If you’re seeking a long-term career in Regulatory Affairs with a globally respected organization, this role offers growth, impact, and the chance to work on innovative healthcare solutions.
⭐ About AstraZeneca
AstraZeneca is a global science-led biopharmaceutical company focused on discovering, developing, and commercializing medicines for critical health challenges. With a culture that encourages innovation, integrity, and diversity, AstraZeneca offers an environment where regulatory professionals can thrive.
🚀 Job Responsibilities
As an Executive – Regulatory Affairs, your key responsibilities include:
Regulatory Documentation & Compliance
- Collate and prepare responses to Health Authority queries.
- Maintain submission trackers and documentation records.
- Ensure adherence to AZ code of conduct, global regulatory policies, and local legislation.
Regulatory Submissions & Dossier Preparation
- Support compilation and submission of:
- NDAs and additional indications
- GCT applications
- Site registrations
- Import licenses
- Assist in query management until approval or closure.
Artwork & Lifecycle Management
- Support development of India-specific artwork aligned with regulatory requirements.
- Manage product license changes and lifecycle updates.
PSUR & Safety Reporting
- Prepare India-specific PSURs based on global PBRER.
- Submit PSURs within timelines and address HA queries.
Regulatory Intelligence
- Track and circulate new guidelines, circulars, and regulatory updates to ensure proactive action.
Audit Support
- Ensure audit-ready documents and participate in internal/external audits.
- Assist in deviations and CAPA implementation.
🎓 Required Qualifications
Essential
- Bachelor’s degree in a relevant life sciences or regulatory field.
- Experience in quality assurance or regulatory affairs within the pharmaceutical industry.
Desirable
- Postgraduate degree in Regulatory Affairs, Pharmaceutical Sciences, or related discipline.
🌟 Why Join AstraZeneca?
- Work in a globally recognized, science-first organization.
- Inclusive culture that values diversity, learning, and collaboration.
- Exposure to high-impact regulatory projects.
- Opportunity to contribute to medicines that make a difference globally.
📍 Job Location
Mumbai, India
💼 How to Apply
