Extensive regulatory experience in biopharmaceutical industry
Thorough knowledge of drug development lifecycle
Strong project management skills for submissions
The Associate Regulatory Affairs Director leads end-to-end planning and execution of regulatory deliverables to turn transformative science into approved medicines
Job Summary
The Associate Regulatory Affairs Director leads end-to-end planning and execution of regulatory deliverables to turn transformative science into approved medicines.
This role involves developing submission strategies, anticipating risks, and driving applications through approval while collaborating across regions and functions.
AstraZeneca offers an inclusive culture that values diverse perspectives and continuous learning to help drive life-changing medicines to patients worldwide.
Matching Summary
The Associate Regulatory Affairs Director leads end-to-end planning and execution of regulatory deliverables to turn transformative science into approved medicines.
Skills & Requirements
Must-have
Extensive regulatory experience in biopharmaceutical industry
Thorough knowledge of drug development lifecycle
Strong project management skills for submissions
Leadership experience leading multi-disciplinary teams
Expertise in Health Authority procedural requirements
Nice-to-have
Managed first wave Marketing Application submissions
Knowledge of AZ Business and internal processes
Experience with complex regulatory deliverables
Cultural awareness and influencing skills
Continuous improvement and knowledge sharing focus
Key Requirements
Relevant University Degree in Science or related discipline
Extensive regulatory experience within the biopharmaceutical industry
Experience at a health authority (alternative path)