International Cmc Regulatory Affairs Associate Director I
AstraZeneca
International cmc regulatory strategy
Project management of regulatory submissions
Gxp principles application
This role leads and manages complex iCMC projects and product ranges across the portfolio, to meet the needs of both AstraZeneca and patients
Job Summary
This role leads and manages complex iCMC projects and product ranges across the portfolio, to meet the needs of both AstraZeneca and patients.
It combines strong project management with tactical regulatory delivery, ensuring international CMC submissions are planned, coordinated and executed to high standards and agreed timelines.
The role partners closely with CMC Product Leads and stakeholders across the organisation to shape and implement innovative, risk-based regulatory strategies.
Matching Summary
This role leads and manages complex iCMC projects and product ranges across the portfolio, to meet the needs of both AstraZeneca and patients.
Skills & Requirements
Must-have
International CMC regulatory strategy
Project management of regulatory submissions
GxP principles application
Risk management in regulatory activities
Global regulatory requirements understanding
Nice-to-have
Lean capability
Quality Risk Management
People management experience
Key Requirements
University Degree in science or technical field
Minimum 10 years of relevant experience
Breadth of knowledge in manufacturing, project, technical and regulatory management
Strong understanding of regulatory affairs globally