Job Title: International CMC Regulatory Affairs Manager I
Global Career Level: D
Role Type: Individual Contributor for International Markets

About AstraZeneca
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines targeting some of the planet’s most reliable diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we 're dedicated to being a Outstanding Place to Work.

About the role
Introduction to role
The role holders effectively manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges (synthetics/biologics) to deliver the needs of both the AZ business and the customer. They project manage international CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product Lifecyle. The role holder will contribute and lead the regulatory CMC components of business-related projects.



They will have effective levels of interactive communication with stakeholders and project team members to ensure relevant timelines and regulatory commitments are communicated.
They will ensure the application of international CMC regulations and guidance within AstraZeneca and lead/contribute to development of recent guidance, policy, and processes.

Accountabilities
Manage the timely preparation (include authoring) and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout marketing authorisation applications and all post approval activities
Accountable for delivering “submission ready” CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures and ensuring submission quality.
Documenting maintenance and communication of Health Authority approval status.
Develops and builds expertise in regional regulatory re

📌 International Cmc Regulatory Affairs Manager I Bengaluru
🏢 AstraZeneca
📍 Bengaluru