International CMC Regulatory Affairs Manager I

This role manages the end-to-end delivery of Chemistry, Manufacturing and Control (CMC) documentation for assigned product ranges. It ensures regulatory submissions meet business needs and patient expectations across the full product lifecycle. The position leads and coordinates international CMC regulatory submissions to deliver activities, data and documentation to the right quality on time.

Lead the planning, preparation, authoring and delivery of CMC content for marketing authorisation applications and post-approval submissions. Coordinate and project manage international CMC submission activities, tracking progress and managing risks. Adapt plans to meet changing priorities and regulatory expectations while maintaining clear documentation of Health Authority approvals.

Maintain strong communication with stakeholders and project teams to ensure timelines, risks and regulatory commitments are understood. Participate in regulatory execution and delivery meetings, providing concise updates and insight to the CMC team. Operate in line with AstraZeneca Values, Code of Ethics and relevant policies.

Build and deepen expertise in regional regulatory requirements to secure compliance and anticipate trends. Share learnings from projects across teams to strengthen collective knowledge. Continuously develop regulatory expertise through proactive recording of Health Authority interactions and commitments.