Regulatory Affairs Manager - Mumbai

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that concentrates on the discovery, development and commercialization of prescription medicines addressing some of the planet’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

Accountabilities:
- Lead or participate as an expert regulatory member of cross-functional teams to provide strategic advice and operational support throughout the regulatory process, including product development, registration, launch, lifecycle management, and post-marketing activities.
- Plan, manage, and deliver complex global and/or regional regulatory submissions, briefing materials, responses to health authorities, and required documentation for all types of applications and maintenance activities.
- Advise senior management, product development teams, and business partners on regulatory strategies, project risks, timelines, and compliance requirements, ensuring that all commitments are clearly communicated and met.




- Drive continuous improvement in submission preparation and delivery processes, including electronic and paper publishing, documentation quality, and compliance with both local and global regulatory standards and AZ policies.
- Identify complex regulatory risks, propose and implement mitigation strategies, and ensure operational and strategic challenges are efficiently addressed.
- Build and maintains effective partnerships and communication channels with internal partners across functions (including Regulatory, R&D;, Operations, Marketing, Manufacturing) as well as external partners such as health authorities, industry consortia, and vendors.
- Ensure that department systems and records accurately reflect regulatory statuses and submissions, promoting robust compliance with internal standards and external regulatory expectations.
- Coach and mentor colleagues, share regulatory expertise, and

📌 Regulatory Affair Manager (Mumbai)
🏢 AstraZeneca
📍 Mumbai