International Associate Regulatory Affairs Director I
AstraZeneca
India
10+ years international regulatory experience
Maa, cle, and lcm application management
Health authority interaction and response
This role focuses on accelerating approvals across diverse international markets to bring life-changing medicines to patients faster
Job Summary
This role focuses on accelerating approvals across diverse international markets to bring life-changing medicines to patients faster.
The successful candidate will manage end-to-end Marketing Authorisation Applications, Clinical Line Extensions, and Life Cycle Management for an oncology portfolio.
Candidates must be willing to relocate within India if not currently based in the job location to join a collaborative in-person environment.
Matching Summary
This role focuses on accelerating approvals across diverse international markets to bring life-changing medicines to patients faster.
Skills & Requirements
Must-have
10+ years international regulatory experience
MAA, CLE, and LCM application management
Health Authority interaction and response
Veeva Systems proficiency
MS Project or Office Timeline Pro skills
Nice-to-have
Experience with global reliance market strategies
Cross-functional stakeholder leadership
Continuous improvement mindset
Cultural awareness in international markets
Key Requirements
Relevant University Degree in Science
10+ years biopharmaceutical regulatory experience
Thorough understanding of International market Regulatory Frameworks