10 years pharmaceutical regulatory affairs experience
Expert knowledge of local regulatory policies
Proven track record in product registrations
The role is responsible for developing and executing local regulatory strategies across assigned products and therapeutic areas to ensure successful registrations
Job Summary
The role is responsible for developing and executing local regulatory strategies across assigned products and therapeutic areas to ensure successful registrations.
Candidates must lead local regulatory teams with a sense of urgency while providing strategic guidance to country-specific Program and Medicine Teams.
AstraZeneca offers an inclusive culture that champions diversity, collaboration, and lifelong learning for employees empowered to push the boundaries of science.
Matching Summary
The role is responsible for developing and executing local regulatory strategies across assigned products and therapeutic areas to ensure successful registrations.
Skills & Requirements
Must-have
10 years pharmaceutical regulatory affairs experience
Expert knowledge of local regulatory policies
Proven track record in product registrations
Strategic direction for pre-approval through post-marketing
Ability to manage complex regulatory challenges
Nice-to-have
Strong interpersonal and communication abilities
Experience fostering collaborative relationships
Demonstrated expertise in ethical conduct
Advanced knowledge of emerging regulations
Proficiency in interpreting GxPs
Key Requirements
Bachelor's degree in life sciences
Minimum 10 years in pharmaceutical regulatory affairs
In-depth understanding of drug development processes
Documented achievements in obtaining product registrations